Instructions
for Completing the MedWatch Form 3500A
Updated: July 27, 2004
Form FDA 3500A ( PDF format)
is a two-sided form. It is for use by user facilities,
distributors, importers, applicants, and manufacturers for MANDATORY reporting
of adverse events and product problems as designated in the
applicable statutes and FDA regulations.
Use the VAERS form (available at http://www.vaers.org)
to report vaccine adverse events.
INDEX
HOW TO OBTAIN FDA 3500A FORMS
AND GUIDANCE ON HOW TO COMPLETE FDA FORM 3500A
Includes information on obtaining bulk copies and where
to send completed forms
GENERAL INSTRUCTIONS
Front Page: Form 3500A
SECTION A: PATIENT
INFORMATION
A1: Patient
identifier
A2: Age
at time of event or Date of birth
A3: Sex
A4: Weight
SECTION B: ADVERSE EVENT OR PRODUCT
PROBLEM
B1: Adverse
event and/or Product problem
B2: Outcomes
attributed to adverse event
B3: Date of event
B4: Date of this report
B5: Describe event or problem
B6: Relevant tests/laboratory
data, including dates
B7: Other relevant history,
including preexisting medical conditions
SECTION C: SUSPECT MEDICATION(S)
C1: Name
C2: Dose,
frequency & route used
C3: Therapy dates
C4: Diagnosis for use
C5: Event abated after use
stopped or dose reduced
C6: Lot #
C7: Expiration date
C8: Event reappeared after
reintroduction
C9: NDC #
C10: Concomitant medical products and
therapy dates
SECTION D: SUSPECT MEDICAL DEVICE
D1: Brand
name
D2: Type
of device
D3: Manufacturer
name & address
D4: Product
identification number/expiration date
D5: Operator
of device
D6: If
implanted, give date
D7: If
explanted, give date
D8: Reprocessed
and reused single-use device?
D9: Reprocessor
name & address
D10: Device
available for evaluation?
D11: Concomitant
medical products and therapy dates
SECTION E: REPORTER
E1: Name,
address & phone #
E2: Health
professional?
E3: Occupation
E4: Initial
reporter also sent report to FDA?
BACK PAGE
SECTION F: FOR USE BY USER FACILITY/DISTRIBUTOR/IMPORTER
- DEVICES ONLY
F1: Check
one
F2: UF/Dist/Importer
report number
F3: User facility
or distributor/Importer name & address
F4: Contact person
F5: Phone Number
F6: Date user facility or distributor/Importer
became aware of event
F7: Type of report
F8: Date of this report
F9: Approximate age of device
F10: Event problem codes
F11: Report sent to FDA?
F12: Location where event occurred
F13: Report sent to manufacturer?
F14: Manufacturer name/address
SECTION G: SECTION G: ALL MANUFACTURERS
G1: Contact
office - name/address (& mfring site for devices)
G2: Phone number
G3: Report source
G4: Date received
by manufacturer
G5: This
block is for use by drug and biologic manufacturers ONLY
G6: If IND, protocol #
G7: Type of report
G8: Adverse event term(s) [for
use by drug and biologic manufacturers ONLY]
G9: Mfr. report number
SECTION H: DEVICE MANUFACTURERS
ONLY
H1: Type
of reportable event
H2: If follow-up,
what type?
H3: Device evaluated
by mfr?
H4: Device manufacture
date
H5: Labeled for
single use?
H6: Evaluation
codes
H7: If remedial
action initiated, check type
H8: Usage of device
H9: Action reported to FDA under
21 USC 360i(f)?, correction/removal number
H10: Additional manufacturer narrative
H11: Corrected data
APPENDIX: ROUTES OF ADMINISTRATION: ICH LIST AND CODES
HOW TO OBTAIN FDA 3500A FORMS AND
GUIDANCE ON HOW TO COMPLETE FDA FORM 3500A
1. Bulk copies of FDA Form 3500A can be obtained
from:
Consolidated Forms and Publications Distribution
Center
Beltsville Service Center
6351 Ammendale Road
Beltsville, MD 20705
2. Copies of FDA Form 3500A and Guidance on
How To Complete FDA Form 3500A may also be obtained
by:
3. Fillable Forms Software
4. Preparing a Facsimile of FDA Form
3500A In place of using the preprinted forms, a computer-generated
facsimile FDA Form 3500A may be used once approval, in writing,
is granted by FDA if the facsimile:
A) Contains all the elements (i.e., 2-column format; sections;
blocks; titles; descriptors within blocks; disclaimer text)
of FDA Form 3500A in the identical enumerated sequence
of the form
- Sections should not be moved to other pages, and should
not exclude any data elements EXCEPT:
- If a drug or biologic manufacturer is reporting
an adverse event in which no suspect medical device
is involved, section G may be identically
reproduced in place of Section D on the front
of the form so that a one page form may be submitted
B) Has, at least, a 1/4" margin around the entire form
so that information is not lost during scanning, photocopying
or faxing of the document
- The left-hand margin may be increased up to 1/2" (all
other margins have to continue to be at least 1/4") to
permit binding (e.g., hole-punching) of the form
C) Includes the name of the reporting company centered
on the top of the front page
D) Includes in the lower left hand corner of the front
page the phrase "3500A Facsimile", instead of the phrase "FDA
Form 3500A (date of form [e.g., 9/05])"
E) Includes in the upper right corner of the front page
above the "FDA Use Only" box the phrase "FDA Facsimile
Approval: [include date of approval by FDA]", instead of
the phrase "See OMB statement on reverse"
F) Data and text contained within the boxes on a facsimile
FDA Form 3500A conform to the following specifications:
1) A font size not less than 10 point
2) A font type that is easy to read (e.g., CG Times, Arial) and not condensed,
because the form may be photocopied or faxed multiple times
- The font type that is used for the data and text
should, if possible, be different than the font type
used to create the FDA Form 3500A for visual contrast
to enhance readability
3) All data and text is contained within each of the
boxes
- e.g., A box marked with an "x" should be centered
within the box and narratives should include margins
so that letters are not obscured or made ambiguous
by lines defining the box
G) Continuation pages containing additional information
for narrative entries incorporate the specific information
detailed in General Instructions (see Page 4). For
approval of computer-generated facsimile FDA Form 3500As,
companies should mail their requests along with two copies
of the facsimile form, one blank and one with all boxes
completed with sample data/text, to:
For Drugs:
Division of Medication Errors
and Technical Support, HFD-420
ODS/CDER/FDA
5600
Fishers Lane Rm 6-34
Rockville
MD 20857
For Medical Devices:
Information and Analysis
Branch, HFZ-531
CDRH/OSB/DSS
1350
Piccard Drive
Rockville,
MD 20850
Note: Companies that are using a computer-generated facsimile
FDA Form 3500A from a vendor that has already obtained approval,
in writing, from FDA for the form do NOT have to submit another
approval request to the agency. The vendor's name and approval
date should appear in the upper right corner of the form.
5. Questions About Reporting?
Drugs: Office of Drug Safety (HFD-400)
Center for
Drug Evaluation and Research
Food and Drug
Administration
5600 Fishers
Lane
Rockville,
MD 20857
Phone: (301)
827-3169
Biologics: Epidemiology Branch (HFM-220)
Center
for Biologics Evaluation and Research
Food
and Drug Administration
1401
Rockville Pike
Rockville,
MD 20852-1448
Phone:
(301) 827-3974
Fax:
(301) 827-3529
Devices: Reporting Systems Monitoring Branch (HFZ-533)
Center
for Devices and Radiological Health
Food
and Drug Administration
1350
Piccard Drive
Rockville,
MD 20850
Phone numbers for specific questions (please use fax numbers except
for emergencies):
- Interpretation of policy: (301) 827-0038 (fax) (301) 594-2735 (voice)
- Individual 3500A or annual reports: (301) 827-0038 (fax) (301) 594-2735
(voice)
- Emergencies outside of normal East Coast business hours: (301) 827-3333
(fax) or (301) 443-1240 (voice-24 hours/ day)
6. Where to Send Mandatory Reporting Forms
Drugs: When duplicate copies are required by regulation:
Central Document Room
Center for Drug Evaluation and Research
Food and Drug Administration
5901-B Ammendale Rd.
Beltsville, Md. 20705-1266
When single copies are required by regulation:
Office of Drug Safety (HFD-400)
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Please call (301) 827-3169 with any further questions regarding
where to send drug mandatory reporting forms
Biologics:
Epidemiology Branch, HFM-220
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
Devices:
MDR Reporting
Center for Devices and Radiological Health
Food and Drug Administration
P.O. Box 3002
Rockville, MD 20847-3002
GENERAL INSTRUCTIONS
- All entries must be typed and printed in a font no smaller than 10
point.
- Complete all sections that apply.
- To complete an item when information is not available, use the following
as appropriate:
- NA for not applicable
- NI for no information at this time (but may become available later)
- UNK for unknown
- Dates should be entered as month/day/year (e.g., June 3, 1999 =
06/03/1999).
If exact dates are unknown, provide the best estimate.
- For narrative entries, if the fields do not provide adequate space,
attach an additional page(s).
The following specific information is to be incorporated:
- Include the phrase continued at the end of each field of
FDA Form 3500A that has additional information continued onto another
page
- Identify all attached pages as Page __ of __
- Indicate the appropriate section and block number next to the narrative
continuation
- Display the User Facility, Distributor (Importer), or Manufacturer
report number in the upper right corner as applicable
- Include the firm's or facility's name in the upper right corner
as well, if the report is from a user facility, distributor (importer),
or manufacturer
- If the case report involves more than two (2) suspect medications
or more than one (1) suspect medical device, submit another copy of
FDA Form 3500A, with only section C or section D filled in as appropriate.
If the event involves more than one suspect medical device, complete
all applicable sections of FDA Form 3500A for the first device and
a separate section D (Suspect Medical Device) and Blocks F9, F10, F13,
and F14 for each additional device. Identify each report as device
1, device 2, etc.
Manufacturers must complete and submit a separate FDA Form 3500A for each
different suspect device. Each 3500A will be given a separate Manufacturer
Report Number.
-
If the suspect medical device is a single use device that has been
reprocessed for use in humans, then the reprocessor is the manufacturer.
The manufacturer can be either an Original Equipment Manufacturer
(OEM), or a Reprocessor of Single-Use Devices, which also can be
a User Facility that reprocesses Single-Use Devices. See the table
below
Subject Device
is: |
Manufacturer
is: |
Single Use Device |
Original Equipment Manufacturer
(OEM) |
Device designed to be reused |
Original Equipment Manufacturer
(OEM) |
Single Use Device, reprocessed
for reuse |
Reprocessor |
Single Use Device, reprocessed
by Hospital or Health Care Facility |
Hospital or Health Care Facility |
- If no suspect medical device is involved in a reported adverse event
(i.e., when reporting ONLY a suspect drug or biologic), ONLY sections
A, B, C, E, and G are to be filled out:
- Section G (All manufacturers) may be substituted for section
D (Suspect medical device) on the front of the form to enable
the submission of a one page form
- If section G is reproduced on the front of the form it must be an
identical reproduction of the original section G
- All submissions must be made in English, including foreign literature
reports.
- Vaccines: Events involving vaccines should be reported to the Vaccine
Adverse Event Reporting System (VAERS) on form VAERS-1( PDF format),
available on the MedWatch website or by calling 1-800-822-7967.
- Devices: Federal law provides that user facility reports that are required
by law may not be used in private civil litigation actions unless the party
who made the report had knowledge the report contained false information.
21 USC 360i(b)(3).
FRONT PAGE
At the top of the front page
Enter the page number and total number of pages submitted (include
attachments in the total) where the words Page __ of __ are indicated.On
the top-right corner of the front page Enter the Manufacturer report
number, User Facility report number, or Distributor (Importer) report
number in the correspondingly labeled box. Enter both report numbers,
if applicable, to cross-reference this report with a report from another
source on the same event. Mfr report # This is the
unique identifier used by the manufacturer for this report. For a follow-up
report, the Manufacturer report number must be identical to the number
assigned to the initial report. The Manufacturer report number is also
entered in block G9 on the back of the form.
For device manufacturers: The report number consists of three components:
the manufacturer's FDA registration number for the manufacturing site
of the reported device, the 4-digit calendar year, and a consecutive
5-digit number for each report filed during the year by the manufacturer
(e.g., 1234567-1997-00001, 1234567-1997-00002). If the manufacturing
site does not have a registration number, then FDA will assign a temporary
one to be used until the site is officially registered.
For drug and biologic manufacturers: The report number (referred to
as the control number on the old 1639 reporting form) can be any number
the manufacturer chooses to uniquely identify the report. If submitting
a follow-up to a report originally obtained from FDA through a MedWatch
to Manufacturer Program transmission of a serious direct report, check
the other box in block G3 and enter the FDA-assigned report number
there.
UF/Dist report #
This is the unique identifier used by the user facility or the distributor
(importer) for this report. For a follow-up report, the UF/Dist report
number must be identical to the number assigned to the initial report.
The UF/Dist report number is also entered in block F2 on the back of
the form.
The user facility report number consists of three components: the facility's
10-digit Health Care Financing Administration (HCFA) number, the 4-digit
calendar year, and a consecutive 4-digit number for each report filed
during the year by the facility (e.g., 1234567890-1997-0001, 1234567890-1997-0002).
If the HCFA number has fewer than 10 digits, enter ONLY these numbers,
leaving the remainder blank (zeros will be automatically filled in by
the system). If a facility does not have a HCFA number, the first report
and any subsequent reports should be submitted with all zeros in the
HCFA space (e.g., 0000000000-1997-0001), and FDA will assign a number
to be used in future reports. If a facility has more than one HCFA number,
the facility must select one of those numbers as the primary number and
use it for subsequent submissions.
If a user facility has multiple sites, the primary site can report centrally
and use one reporting number for all sites IF the primary site provides
the name, address, and HCFA number for each respective site.
The distributor (importer) report number consists of three components:
the FDA-assigned registration or identification number for the distributor
(importer) of the device, the 4-digit calendar year, and a consecutive
5-digit number for each report filed during the year by the distributor
(importer) (e.g.,1234567-1997-00001, 1234567-1997-00002). If a distributor
(importer) does not have an assigned identification number, it should
use all zeros in the appropriate space on the initial report, and continue
to use zeros on subsequent reports until the FDA-assigned number is received.
The distributor (importer) would still enter the 4-digit calendar year
and 5-digit sequence number.
Note: In cases where a reporting site is registered as both a manufacturer
and a distributor (importer), and the registration and/or FDA-assigned
identification numbers are identical for both, then the 5-digit sequence
number for reports submitted during the year by either one may NOT be
duplicated. For example, for devices manufactured by the firm, the report
number would consist of the registration number, calendar year, and a
consecutive 5-digit number (e.g., 1234567-1997-00001, 1234567-1997-00002,
and so on). For devices distributed (imported) by the firm, the registration
number and year would remain the same, but the 5-digit sequence number
must be different (e.g., 1234567-1997-00003, 1234567-1997-00004, and
so on).
SECTION A: PATIENT INFORMATION
Complete a separate form for each patient, unless the report involves
a medical device where multiple patients were adversely affected through
the use of the same device.
In that case:
- Indicate the number of patients in block B5 (Describe event or
problem)
- Complete separate section A and blocks B2, B5, B6, B7, D11, F2 and
F10 for each additional patient
Enter the corresponding patient identifier in block A1 for each patient
involved in the event
Note: When a newborn baby is found to have a congenital anomaly that
the initial reporter considers possibly associated with a product administered
to the mother during pregnancy, the patient is the newborn baby.
Parent-child/fetus report(s) are those cases in which either a
fetus/suckling infant or the mother, or both, sustain an adverse
event that the initial reporter considers possibly associated with a
product administered to the mother during pregnancy. Several general
principles are used for filing these reports:
- If there has been no event affecting the child/fetus, report only
on the parent
- For those cases describing fetal demise or spontaneous abortion,
only a parent report is applicable
- When ONLY the child/fetus has an adverse reaction/event (other than
spontaneous abortion/fetal demise), the information provided in section
A applies to the child/ fetus, and characteristics concerning the parent
who was the source of exposure to the product is to be provided in
section C.
If both the parent and the child/fetus sustain adverse events, two reports
should be provided and linked using the narrative (include the manufacturer
control #=s in block B5)
Note: Submitted adverse event/product problem report forms can be obtained
under the Freedom of Information (FOI) Act, with patient and reporter
identifying information deleted.
Thus, when a patient is the reporter, there should be no reason
not to provide the patient name as initial reporter, since such information
is not releasable under FOI. However, a company can use the term "Consumer-Confidential",
provided that should FDA request to contact that patient, the information
would be made available to FDA.
A1: Patient identifier
Provide the patient's initials or some other type of identifier
that will allow both the submitter and the initial reporter (if different)
to locate the case if contacted for follow-up. Do not use the patient's
name or social security number.
The patient's identity is held in strict confidence by FDA and protected
to the fullest extent of the law.
If no patient was involved, enter none.
A2: Age at time of event or Date of birth
Provide the most precise information available. Enter the patient's birthdate,
if known, or the patient's age at the time of event onset. For age, indicate
time units used (e.g., years, months, and days).
- If the patient is 3 years or older, use years (e.g., 4 years)
- If the patient is less than 3 years old, use months (e.g., 24 months)
- If the patient is less than 1 month old, use days (e.g., 5 days)
- Provide the best estimate if exact age is unknown
A3: Sex
Enter the patient's gender. If the adverse event is a congenital anomaly,
report the sex of the child.
A4: Weight
Indicate whether the weight is in pounds (lbs.) or kilograms (kgs). Make
a best estimate if exact weight is unknown.
SECTION B: ADVERSE EVENT OR PRODUCT PROBLEM
B1: Adverse event and/or Product problem
Choose the appropriate box. Both boxes should be checked if a product
problem may have caused or contributed to the adverse event.
Adverse event:
Any incident where the use of a medication (drug or biologic), at
any dose, or a medical device (including in vitro diagnostics)
is suspected to have resulted in an adverse outcome in a patient.
Product problem (e.g., defects/malfunctions):
Any report regarding the quality, performance, or safety of any
medical product. This category is selected when reporting device
malfunctions that could lead to a death or serious injury if the
malfunction were to recur.
B2: Outcomes attributed to adverse event:
Indicate ALL that apply to the reported event:
Drugs and Biologics: Only mark a box in this section if the
adverse event meets the regulatory definition of serious in 21 CFR
314.80(a).
Death: Check ONLY if the death was an OUTCOME of the adverse
event, and include the date if known.
DO NOT check if:
- The patient happened to die while using a medical product, but
there was no suspected association between the death and the use
of the product
- A fetus is aborted because of a congenital anomaly, or is miscarried
Life-threatening: Check if suspected that:
- The patient was at substantial risk of dying at the time of
the adverse event, or
- Use or continued use of the device might have resulted in the
death of the patient
Hospitalization (initial or prolonged): Check if admission
to the hospital or prolongation of hospitalization was a result of
the adverse event.
Disability: Check if the adverse event resulted in a substantial
disruption of a person's ability to conduct normal life functions.
Congenital anomaly: Check if suspected that exposure to a medical
product prior to conception or during pregnancy may have resulted in
an adverse outcome in the child.
Required intervention to prevent permanent impairment or damage:
if either situation may be due to the use of a medical device and medical
or surgical intervention was necessary to:
- Preclude permanent impairment of a body function, or
- Prevent permanent damage to a body structure.
Other: Check ONLY if the other categories are not applicable
to the event. Briefly describe the patient outcome in the space provided.
The actual narrative of the event will be entered in block B5.
Drugs and Biologics: Check Other only if the alternate categories
for a serious outcome are not applicable to the event, but the event
is considered an "important medical event" as defined in the regulations
21 CFR 314.80. Do Not use this box to indicate nonserious outcomes.
B3: Date of event
Provide the actual or best estimate of the date of first onset of the adverse
event. If day is unknown, month and year are acceptable. If day and month
are unknown, year is acceptable.
- When a newborn baby is found to have a congenital anomaly, the
event onset date is the date of birth of the child
- When a fetus is aborted because of a congenital anomaly, or
is miscarried, the event onset date is the date pregnancy is terminated.
If information is available as to time during pregnancy when exposure occurred,
indicate that information in narrative block B5.
B4: Date of this report
Drugs and Biologics: The date the report is filled out.
Devices: The date the initial reporter provided the information
about the event
[i.e., the first person or entity who initially provided the information
to the user facility, manufacturer, or distributor (importer)].
B5: Describe event or problem
For an adverse event: Describe the event in detail using the reporter's
own words, including a description of what happened and a summary
of all relevant clinical information (medical status prior to the
event; signs and/or symptoms; differential diagnosis for the event
in question; clinical course; treatment; outcome, etc.). If available
and if relevant, include synopses of any office visit notes or the
hospital discharge summary. To save time and space (and if permitted
by the institution), attach copies of these records with any confidential
information deleted. DO NOT identify any patient, physician, or institution
by name. The initial reporter's identity should be provided in full
in section E. Information as to any environmental conditions
that may have influenced the event should be included, particularly
when (but not exclusive to) reporting about a device.
- Results of relevant tests and laboratory data should be entered
in block B6.(see instructions for B6).
- Preexisting medical conditions and other relevant history
belong in block B7. Be as complete as possible, including
time courses for preexisting diagnoses (see instructions for
B7).
For a product problem: Describe the problem (quality, performance,
or safety concern) in sufficient detail so that the circumstances
surrounding the defect or malfunction of the medical product can
be understood. If available, the results of any evaluation of a malfunctioning
device and, if known, any relevant maintenance/service information
should be included in this section.
B6: Relevant tests/laboratory data,
including dates:
Provide all appropriate information, including relevant negative test
and laboratory findings, in order to most completely convey how the
medical work-up/assessment led to strong consideration of medical-product-induced
disease as etiology for clinical status, as other differential diagnostic
considerations were being eliminated.
Include:
- Any relevant baseline laboratory data prior to the administration
or use of the medical product
- All laboratory data used in diagnosing the event
- Any available laboratory data/engineering analyses (for devices)
that provide further information on the course of the event
If available, include:
- Any pre- and post-event medication levels and dates (if applicable)
- Synopses of any relevant autopsy, pathology, engineering, or
lab reports
If preferred, copies of any reports may be submitted as attachments, with
all confidential information deleted. DO NOT identify any patient, physician
or institution by name. The initial's reporter's identity should be provided
in full in section E.
B7: Other relevant history, including
preexisting medical conditions:
If available, provide information on:
- Other known conditions in the patient, e.g.,
- Hypertension
- Diabetes mellitus
- Renal/hepatic dysfunction, etc.
- Significant history
- Race utilizing the following names and definitions:
| Name |
Definition |
| American
Indian or Alaska Native |
American Indian
or Alaska Native |
| Asian |
Asian Continent
to include Indian Subcontinent |
| Native
Hawaiian or Other Pacific Islander |
Native Hawaiian
or Other Pacific Islander |
| Black
or African American |
Black, not of Hispanic
origin |
| Hispanic
or Latino |
Hispanic |
| White |
White, not of Hispanic
origin |
- Allergies
- Pregnancy history
- Smoking and alcohol use
- Drug abuse, etc.
SECTION C: SUSPECT MEDICATION(S)
For adverse event reporting, a suspect medication is one that the initial
reporter suspected was associated with the adverse event. In block C10
enter other concomitant medical products (drugs, biologics, medical devices,
etc.) that the patient was using at the time of the event but are NOT
thought by the initial reporter to be involved in the event.
Up to two (2) suspect medications may be reported on one form (#1=first
suspect product, #2=second suspect product). Attach an additional form
if there were more than two suspect medications for the reported adverse
event.
C1: Name:
Use the trade name as marketed. If unknown or if no trade name, use
the generic name (with the manufacturer or labeler's name, if known).
For foreign reports, use both the foreign trade name and the U.S. generic
name.
C2: Dose, frequency & route used:
Describe how the product was used by the patient (e.g., 500 mg QID
orally or 10 mg every other day IV). For reports involving overdoses,
the amount of product used in the overdose should be listed, NOT the
prescribed amount.
- See APPENDIX for list of Routes of Administration
C3: Therapy dates:
Provide the date administration was started (or best estimate) and
the date stopped (or best estimate). If no dates are known, an estimated
duration is acceptable (e.g., 2 years) or, if therapy was less than
one day, then duration is appropriate (e.g., 1 dose or 1 hour for an
IV).
C4: Diagnosis for use
Provide the indication for which the product was prescribed or used
in this particular patient.
C5: Event abated after use stopped or dose reduced:
In addition to checking the appropriate box, provide supporting lab
tests and dates, if available, in block B6.
C6: Lot #:
If known, include the lot number(s) with all product problem reports,
or any adverse event report with a biologic or medication.
C7: Expiration date:
Include with all product problem reports ONLY.
C8: Event reappeared after reintroduction:
In addition to checking the appropriate box, provide supporting lab
tests and dates, if available, in block B6.
C9: NDC #:
The national drug code is required ONLY when reporting a drug product
problem. It can be found on the product label and/or packaging. Zeros
and dashes should be included as they appear on the label.
C10: Concomitant medical products and therapy dates:
List and provide therapy dates for any other medical products (drugs,
biologics, medical devices, etc.) that a patient was using at the time
of the event. DO NOT include products used to treat the event.
SECTION D: SUSPECT MEDICAL DEVICE
In block D11, report other concomitant medical products (drugs, biologics,
medical devices, etc.) that the patient was using at the time of the event
but are not thought to be involved in the event.
D1: Brand name:
The trade or proprietary name of the suspect medical device as used
in product labeling or in the catalog (e.g., Flo-Easy Catheter, Reliable
Heart Pacemaker, etc.). This information may 1) be on a label attached
to a durable device, 2) be on a package of a disposable device, or 3)
appear in labeling materials of an implantable device.
Single use reprocessed devices may bear the OEM's brand name. If the suspect
device is a reprocessed single-use device, enter "NA".
D2: Type of device:
The generic or common name of the suspect medical device or a generally
descriptive name (e.g., urological catheter, heart pacemaker, patient
restraint, etc.). Do not use broad generic terms such as "catheter", "valve", "screw",
etc.
D3: Manufacturer name & address:
If available, enter the full name and mailing address of the manufacturer
of the suspect medical device. If Block D8 below is 'Yes", enter the
name and address of the reprocessor.
D4: Product identification number/expiration
date:
If available, provide any expiration date or any or all identification
numbers associated with the suspect medical device exactly as they appear
on the device or device labeling. This includes spaces, hyphens, etc.
Model #: The exact model number found on the device label or accompanying
packaging
Catalog #: The exact number as it appears in the manufacturer's catalog,
device labeling, or accompanying packaging
Serial #: This number can be found on the device label or accompanying
packaging; it is assigned by the manufacturer and should be specific
to each device
Lot #: This number can be found on the label or packaging material
Expiration date: If available; this date can often be found on the device
itself or printed on the accompanying packaging.
Other #: Any other applicable identification number (e.g., component
number, product number, part number, barcoded product ID, etc.)
D5: Operator of device:
Indicate the type (not the name) of person operating or using the suspect
medical device on the patient at the time of the event as follows:
- Health professional = physician, nurse, respiratory therapist, etc.
- Lay user/patient = person being treated, parent/spouse/friend of the
patient
- Other = nurses aide, orderly, etc.
D6: If implanted, give date:
For medical devices that are implanted in the patient, provide the implant
date or best estimate. If day is unknown, month and year are acceptable.
If month and day are unknown, year is acceptable.
D7: If explanted, give date:
If an implanted device was removed from the patient, provide the explant
date or best estimate. If day is unknown, month and year are acceptable.
If month and day are unknown, year is acceptable.
D8: Is this a Single-use Device that was Reprocessed and Reused
on a Patient?
Indicate "Yes" or "No"
If the original equipment manufacturer (OEM) is unable to determine
if their single use device was reprocessed and reused on a patient, then
the OEM should enter 'UNK' in Block D8 and in Block H10 (Additional Manufacturer
Narrative) describe the efforts made to obtain the information and any
responses.
D9: If Item No.8 is "Yes", Enter Name and Address of Reprocessor:
Enter the name and address of the reprocessor of the single-use device.
Any entity that reprocesses single-use devices for reuse in humans is
the manufacturer of the reprocessed single-use device.
D10 : Device available for evaluation?
Indicate whether the device is available for evaluation by the manufacturer.
Indicate if the device was returned to the manufacturer and, if so, the
date of the return.
Do not send the device to FDA.
D11 : Concomitant medical products and therapy dates:
List and provide product names and therapy dates for any other medical
products (drugs, biologics, medical devices, etc.) that the patient was
using at the time of the event. DO NOT include products used to treat
the event.
SECTION E: REPORTER
Indicate the person who initially reported the adverse event to the
user facility, distributor (importer), or manufacturer.
E1: Name, address & phone #:
Please provide the name, mailing address, and phone number of the
person who initially reported the adverse event to the user facility,
manufacturer, or distributor (importer), and who can be contacted to
provide information on the event if follow-up is necessary. If available,
provide reporter's E-mail address and/or fax number.
For medical device reporting by user facilities, this person may or
may not be the designated medical device reporting (MDR) contact.
E2: Health professional?:
Indicate whether the initial reporter is a health professional (e.g.,
physician, pharmacist, nurse, etc.) or not. If not a health professional,
complete block E3 by filling in NA.
E3: Occupation:
Indicate the initial reporter's occupation (particularly type of health
professional), and include specialty if appropriate.
E4: Initial reporter also sent report to FDA:
Indicate whether the initial reporter also notified or submitted a
copy of this report to FDA.
BACK PAGE
At the top of the back page, enter the page number and total number of
pages submitted (include attachments in the total) where the words Page __
of __ are indicated.
SECTION F: FOR USE BY USER FACILITY/DISTRIBUTOR/IMPORTER - DEVICES
ONLY
F1: Check one:
Indicate whether the report is from a user facility or distributor (importer).
F2: UF/Distributor (Importer) report number:
Enter the complete number of the report exactly as entered in the
upper right corner of the front page. For a follow-up report, the UF/Distributor
(Importer) report number must be identical to the number assigned to
the initial report. See instructions on front page for further explanation
of UF/Distributor (Importer) report number.
F3: User facility or distributor/importer name & address:
Enter the full name and address of the user facility or distributor
(importer) reporting site.
F4: Contact person:
Enter the full name of the medical device reporting (MDR) contact
person. This is the person designated by the facility's most responsible
person as the device user facility/distributor (importer) contact for
this requirement. FDA will conduct its MDR correspondence with this
individual. The contact person may or may not be an employee of the
facility. However, the facility and its responsible officials will
remain the parties ultimately responsible for compliance with the MDR
requirements.
F5: Phone Number:
Enter the phone number of the MDR contact person.
F6: Date user facility or distributor became aware of event:
Enter the date that the user facility's medical personnel or the distributor
(importer) became aware that the device has or may have caused or contributed
to the reported event.
F7: Type of report:
Check the appropriate box to identify the type of report being filed,
i.e., an initial report of an event or a follow-up to a previously
submitted report.
If a follow-up report, make sure that the UF/Distributor/Importer
report number for the previously submitted initial report is recorded
in block F2. In the blank provided in block F7, record the appropriate
sequence of follow-up to that particular initial report (e.g., first
follow-up report=follow-up #1, second follow-up report=follow-up #2,
and so on).
Follow-up reports should not repeat material that was submitted in
the initial report, but should ONLY provide additional or corrected
information on the previously reported event.
F8: Date of this report:
Enter the date that the report was forwarded to the manufacturer and/or
the FDA.
F9: Approximate age of device:
Enter the age of the device or a best estimate (include unit of time
used: e.g., month, year).
F10: Event problem codes (refer to Device
Coding Manual for Form 3500A):
Enter up to 3 "patient" and 3 "device" codes from the Codes
Manual that most accurately describe the event. Patient codes
describe what happened to the patient as a result of the event and
device codes describe device failures or problems encountered during
the event. If more than 3 "patient" codes or more than 3 "device" codes
are needed, record them on a separate sheet, mark it "F10", and provide
the report number and page number.
If a user facility or an importer has reason to believe that a reused
device has or may have caused or contributed to an adverse event, the
device problem code 1537 ("Reuse") should be entered in F10 along with
any other applicable device and/or patient-related codes.
F11: Report sent to FDA?:
Check yes or no and indicate the date sent, if applicable.
F12: Location where event occurred:
Check the location of the actual occurrence of the event. If none
of the designated location options apply, check the other box
and provide the location.
F13: Report sent to manufacturer?:
Check yes or no and indicate the date sent, if applicable.
F14: Manufacturer name/address:
Enter full name and address of the device manufacturer, if available.
If the manufacturer is a reprocessor of a single-use device, the name
and address should be identical to the information in Block D9.
SECTION G: ALL MANUFACTURERS
This section is to be filled out by all manufacturers. NOTE:
If a drug or biologic manufacturer is reporting an adverse event in which
no suspect medical device is involved, section G may be identically reproduced
in place of Section D on the front of the form so that a one page form
may be submitted.
G1: Contact office - name/address (& mfring
site for devices):
Enter the full name and address of the manufacturer reporting site [contact
office], including contact name. If the manufacturing site of the device
is not the same as the contact office, enter site and the
name and address of the manufacturing site after the contact office
name and address.
G2: Phone number:
Enter the telephone number of the contact office (devices) or
a representative knowledgeable about the report (drugs; biologics).
G3: Report source:
Check the box(es) that most accurately describe(s) how the manufacturer
[contact office] became aware of the reported adverse event or from
where the information about the adverse event originated.
- Foreign: Foreign sources include foreign governments, foreign affiliates
of the application/license holder, foreign licensors and licensees,
foreign medical facilities, etc. The country of origin should be included.
- Study: Postmarketing, clinical trial, surveillance, or other study
that involves a systematic collection of adverse events from a protocol
designed specifically to investigate product safety.
- Drugs and Biologics: This also includes information derived
from planned contacts and active solicitation of information from patients
(e.g., company- sponsored patient support programs and disease management
programs).
Applicants, manufacturers, and licensed manufacturers should not report
safety information obtained through these types of patient contacts unless
the adverse event meets the regulatory definitions of serious and unexpected and
there is a reasonable possibility that the drug or biological product
caused the adverse experience.
- Literature: If the report source is the scientific literature
or an unpublished manuscript, a copy of the article or manuscript
must be attached. Foreign language articles should be translated
into English. Record the date of the article as the date of the
event (block B3), and provide a full literature citation in block
H10.
Drugs and Biologics: A separate 3500A form must be completed
for each identifiable patient described in the article or manuscript.
- Consumer (including attorneys): Additional information, whenever
possible, should be sought from the treating healthcare provider.
A determined effort should be made to obtain additional detailed
information from health professionals for all serious reactions,
adverse events & product problems initially reported by consumers.
When this additional information is obtained, the follow-up report
should check health professional rather than consumer in block
G3.
- Health professional: Physician, pharmacist, nurse, etc.
- User facility: User facility should be checked if the
manufacturer received the report from the MDR contact in a user
facility as identified in section F. The health professional
should be listed as the initial reporter on the front page of
the form.
- Company representative: This check box would be selected if
a company representative reported the event to the contact office
based on information received from a health professional. The
health professional should be listed as the initial reporter
in Section E.
- Distributor: This check box would be selected for a report
received from the distributor (importer) of the suspect product.
The health professional or other reporter should be listed as
the initial reporter on the front page of the form.
- Other: Any source not covered by the previous categories.
For drug and biologic manufacturers, this check box would
be selected when submitting a follow-up to a report originally
obtained from FDA through a MedWatch to Manufacturer program
transmission of a serious direct report, and the FDA-assigned
report number entered into the space provided.
Other may also be used to identify when the source is another
manufacturer - include the Manufacturer Report Number of the other
manufacturer.
G4: Date received by manufacturer:
This means the date when the applicant, manufacturer, corporate affiliate,
etc. receives information that an adverse event or medical device malfunction
has occurred. This would apply to a report received anywhere in the world.
- Follow-up reports: Use the date that the follow-up information was
received.
G5: This block is for use by drug
and biologic manufacturers ONLY:
Provide whatever information is applicable to the suspect medication identified
in section C.
If the report lists two products by the same applicant as suspect, the
report should be submitted to the application file of the product thought
by the initial reporter to be the more likely cause of the adverse event.
If they are equally suspect, the report should be submitted to the application
file of the product that is first alphabetically.
(A)NDA #: The abbreviated new drug application or the new drug application
(NDA) number. The report should be filed to the first approved NDA if a
product has several NDAs and the specific one cannot be determined
IND #: The investigational new drug (IND) application number
PLA #: Composed of the 4-digit U.S. License Number followed by a slash,
followed by the 4-character Product Code
Pre-1938: Check the box if the suspect medication was marketed prior to
1938 and does not have an NDA #
OTC Check the box if the suspect medication can be purchased over- Product:
the-counter (without a prescription)
G6: If IND, protocol #:
This block is for use by drug and biologic manufacturers ONLY. If
the form is being used as a written IND safety report, enter the protocol
number.
G7: Type of report:
Select ALL the check boxes that apply to reported event:
5-day: As specified in the device regulations, for reports of adverse
events that necessitate remedial action to prevent an unreasonable
risk of substantial harm to the public health, or are required by FDA
by written notice.
10-day : As specified in the device regulations,
for adverse event reports of death and serious injury from user facilities.
15-day: As specified in the drug and biologic regulations, for reports
of serious and unexpected adverse events
Periodic: As specified in the drug and biologic regulations, for reports
of serious labeled and non-serious (labeled and unlabeled) adverse events
Initial: Check if the report is the first submission of a manufacturer
report. For devices, this is the 30-day report
Follow-up: Check if the report is a follow-up to a previously submitted
report. Follow-up reports on devices should NOT repeat material that
was submitted in the initial report, but should ONLY provide additional
or corrected information on the previously reported event. Follow-up reports
on drugs and biologics should contain information that was submitted in
the original report if the information is still correct.
If a follow-up report, make sure that the manufacturer report number
for the previously submitted initial report is recorded in block G9.
In the blank provided in block G7 after follow-up, record the appropriate
sequence of follow-up to that particular initial report (e.g., first
follow-up report=follow-up #1, second follow-up report=follow-up #2,
and so on).
For drug and biologic manufacturers: If submitting a follow-up to a
report originally obtained from FDA through a MedWatch to Manufacturer
program transmission of a serious direct report, check the other box
in block G3 and enter the FDA-assigned report number there.
G8: Adverse event term(s) [for
use by drug and biologic manufacturers ONLY]:
Include a list of adverse event terms that most accurately characterize
the adverse event described in narrative format in block B5. Terms
should be listed with the most important term(s) first. The terminology
may be an accepted standard (e.g., MEDDRA or WHOART), a verbatim term,
or the manufacturer's own terminology. G9: Mfr. report
number:
Enter the Manufacturer report number exactly as it appears in the upper right
corner of the front page. For a follow-up report, the Manufacturer report
number must be identical to the number assigned to the initial report (see
Page 8).
For drug and biologic manufacturers: The report number (referred to as
the control number on the old 1639 reporting form) can be any number the
manufacturer chooses to uniquely identify the report. If submitting a follow-up
to a report originally obtained from FDA through a medWatch to Manufacturer
program transmission of a serious direct report, check the other box
in block G3 and enter the FDA-assigned report number there.
SECTION H: DEVICE MANUFACTURERS ONLY
H1: Type of reportable event:
Check the appropriate box. These choices represent the categories
of events that device manufacturers are required to report.
Death: Check ONLY if the death was an OUTCOME of the adverse event.
Serious injury: An adverse event that is life-threatening; results
in permanent impairment of a body function or permanent damage to
a body structure; or necessitates medical or surgical intervention
to preclude permanent impairment of a body function or permanent
damage to a body structure.
Malfunction: See the guidelines. ("See the guidelines" refers to
the applicable sections in 21 CFR Part 803 reporting guidelines associated
with device malfunctions).
Other: This option is intended to capture reports that the manufacturer
believes the agency should be aware of that are not covered by death,
serious injury, or malfunction as these terms are defined by the
statute, regulation, or guidelines. This type of event category should
be rarely used.
H2: If follow-up, what type?:
Check the box(es) that most accurately describes the nature of the follow-up
report.
Correction: Changes to previously submitted information.
Additional information: Information concerning the event that was
not provided in the initial report because it was not known/available
when the report was originally submitted.
Response to FDA request: Additional information requested by FDA concerning
the device/event.
Device evaluation: Evaluation/analysis of device.
H3: Device evaluated by mfr?:
Check the box marked not returned to mfr. if an evaluation
could not be made because the device was not returned to, or made
available to, the manufacturer. Check the box marked yes if
an evaluation was made of the suspect or related medical device.
If an evaluation was conducted, attach a summary of the evaluation
and check the box marked evaluation summary attached. If an
evaluation of a returned suspect or related medical device was not
conducted, check the box marked no and attach a page to explain
why not or provide the appropriate code from the codes
manual in the space provided.
H4: Device manufacture date:
Enter the month and year of manufacture of the suspect medical
device using a MM/YYYY date format.
H5: Labeled for single use?:
Indicate whether the device was labeled for single use or not.
If the question is not relevant to the device being reported (e.g.,
an X-ray machine), check no.
H6: Evaluation codes:
Enter the applicable codes from the codes
manual for one or more of the categories listed. Conclusion
codes must be entered even if the device was not evaluated.
If the reuse of a device may have caused or contributed to the adverse
event, then the appropriate manufacturer Result codes are to be entered
from the codes manual.
Applicable reuse codes are 230-233 and may be used alone or with
any other applicable results codes. (see H8).
H7: If remedial action initiated,
check type:
Indicate the applicable action(s). If other, specify the type of
action in the space provided. Most of these terms are defined or
further explained in the Act or in the FDA regulations concerning
remedial action (see 21 USC 360h and 21 CFR Parts 7, 803 and 806).
H8: Usage of device:
Indicate whether the use of the suspect medical device was the initial
use, reuse, or unknown.
If a manufacturer receives an adverse event report that indicates
that the event was caused by or contributed to by reuse of a single
use device they manufactured, this block is to be appropriately marked
and the facts of the firm's investigation provided with an explanation
of how the reuse of the product contributed to the outcome. The appropriate
manufacturer Result codes for reuse are also to be entered into H6.
H9: If action reported to FDA under 21 USC
360i(f), list correction/removal reporting number:
H10: Additional manufacturer
narrative:
H11: Corrected data:
Provide the following additional, corrected, or missing information,
identifying each data item by the applicable section and block number:
- Any information missing on the user facility or distributor (importer)
report, including any missing or incomplete event codes required
by block F10
- Information corrected on the user facility or distributor (importer)
report form after verification, including any corrected event codes
required by section D (e.g., D6: model number)
- For each event provided in block F10, an indication of whether
the type of event represented by the code is addressed in the device
labeling, and
- An explanation of why any required information was not provided
and the steps taken to obtain such information.
Appendix
ROUTES OF ADMINISTRATION: ICH LIST AND CODES
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