Instructions for Completing the MedWatch Form 3500

Updated: April 27, 2004

For use by health professionals and consumers for VOLUNTARY reporting of adverse events and product problems with medications (drugs or biologics, except vaccines), medical devices (including in vitro diagnostics), special nutritional products (dietary supplements, infant formulas, medical foods) and other FDA-regulated medical products. Events involving vaccines should be reported to the Vaccine Adverse Event Reporting System (VAERS) (http://www.fda.gov/cber/vaers/report.htm).

Note for consumers: If possible, please take the 3500 form to your health professional (e.g., doctor or pharmacist) so that information based on your medical record that can help in the evaluation of your report will be provided. If, for whatever reason, you do not wish to have your health professional fill out the form, you are welcome to do so yourself.

GENERAL INSTRUCTIONS

• Please make sure that all entries are either typed, printed in a font no smaller than 10 point, or written using black ink.

• Please complete all sections that apply to your report.

• 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, 1998 = 06/03/1998).
  If exact dates are unknown, please provide the best estimate (see B3).

• For narrative entries, if the fields do not provide adequate space, attach an additional page(s) as needed.

Please incorporate the following specific information:

• Identify all attached pages as Page __ of __

• Indicate the appropriate section and block number next to the narrative continuation

• Include the phrase continued at the end of each field that has additional information continued onto another page

• If the case report involves more than two (2) suspect medications, please submit another copy of FDA Form 3500, with only section C or section D filled in as appropriate.

• Section C [Suspect medication(s)] may be used to report on special nutritional products as well as drugs or biologics.

• If your report involves a serious adverse event with a device and it occurred in a facility other than a doctor's office, that facility may be legally required to report to FDA and/or the manufacturer. Please notify the person in that facility who would handle such reporting.

QUESTIONS ABOUT REPORTING?

Call MedWatch at

1-800-FDA-1088
(1-800-332-1088)

INDEX

To read instructions for a specific section, click a link from the list below.

SECTION A: PATIENT INFORMATION

A1:     Patient identifier
A2:     Age at time of event or Date of birth
A3:     Sex
A4:     Weight

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:     Also reported to
E5:     Release of reporter's identity to the manufacturer

APPENDIX I: ROUTES OF ADMINISTRATION: ICH LIST AND CODES

SECTION A: PATIENT INFORMATION

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.

• 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)

• For devices, one form can be used in this circumstance

A1:    Patient identifier

Please provide the patient's initials or some other type of identifier that will allow you, the reporter, to readily locate the case if you are contacted for more information. 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 (such as may be the case with a product problem), enter none.

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, 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

Enter the patient's gender. If the adverse event is a congenital anomaly, report the sex of the child.

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

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, a medical device (including in vitro diagnostics) or a special nutritional product (e.g., dietary supplement, infant formula or medical food) is suspected to have resulted in an adverse outcome in a patient.

To report, it is not necessary to be certain of a cause/effect relationship between the adverse event and the use of the medical product(s) in question. Suspicion of an association is sufficient reason to report. Submission of a report does not constitute an admission that medical personnel or the product caused or contributed to the event.

Please limit your submissions to those events that are serious. An event is classified as serious when the patient outcome is:

Please see instructions for block B2 for further information on each of these criteria.

While voluntary MedWatch reporting with Form 3500 is designed for serious reports only, you are welcome to report even if your case does not meet any of these specific criteria and you feel strongly that FDA should review the report. In that situation, you should check the other box and specify the reason for reporting, including patient outcome, in the space provided. The actual narrative of the event should be entered in block B5.

Product problem (e.g., defects/malfunctions): Any report regarding the quality, performance, or safety of any medication, medical device or special nutritional product. In addition, please select this category when reporting device malfunctions that could lead to a death or serious injury if the malfunction were to recur.

Product problems include, but are not limited to, such concerns as:

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Death: Check only if you suspect that 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 or other medical product 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.

Do not check if:

• A patient in the hospital received a medical product and subsequently developed an otherwise nonserious adverse event, unless the adverse event prolonged the hospital stay

Do check if:

• A patient is admitted to the hospital for one or more days, even if released on the same day

• An emergency room visit results in admission to the hospital

Emergency room visits that do not result in admission to the hospital should be evaluated for one of the other serious outcomes (e.g., life-threatening; required intervention to prevent permanent impairment or damage)

Disability: Check if the adverse event resulted in a substantial disruption of a person's ability to conduct normal life functions. Such would be the case if the adverse event resulted in a significant, persistent or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities and/or quality of life.

Congenital anomaly: Check if you suspect 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: Check if you believe that medical or surgical intervention was necessary to preclude permanent impairment of a body function, or prevent permanent damage to a body structure, either situation suspected to be due to the use of a medical product.

Drugs and Biologics: This box should be checked for important medical events that may be considered a serious adverse experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the other serious outcomes listed above. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.

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.

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.

The date the report is filled out.

For an adverse event:

Describe the event in detail, 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 your institution), please attach copies of these records with any confidential information deleted. Do not identify any patient, physician, or institution by name. The 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).

If it is determined that reuse of a medical device labeled for single use may have caused or contributed to an adverse patient outcome, please report in block B5 the facts of the incident and the perceived contribution of reuse to the occurrence.

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
• For a medication or special nutritional product problem, please indicate if you have retained a sample that would be available to FDA

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B6:    Relevant tests/laboratory data, including dates

Please 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.

Please 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, please 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.

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B7:    Other relevant history, including preexisting medical conditions

Knowledge of other risk factors can help in the evaluation of a reported adverse event. 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
    Am. Indian – 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	Black, not of Hispanic origin
    Hispanic	Hispanic
    White	White, not of Hispanic origin

 

• Allergies 
• Pregnancy history
• Smoking and alcohol use
• Drug abuse, etc.

 

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SECTION C: SUSPECT MEDICATION(S)

For adverse event reporting:

A suspect medication is one that you suspect is 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 which you do not think were 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.

For product problem reporting:

A suspect medication is the product that is the subject of the report. A separate form should be submitted for each individual product problem report.

Identification of the labeler/distributor and pharmaceutical manufacturer (if known) and labeled strength of the product is important for prescription or non-prescription products.

This section may also be used to report on special nutritional products (e.g., dietary supplements, infant formula or medical foods) or other products regulated by FDA.

If reporting on a special nutritional or a drug product problem, please attach labeling/ packaging if available.

If reporting on a special nutritional only, please provide directions for use as listed on the product labeling.

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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 quality problem reports, please include the manufacturer's name and the labeled strength for both prescription and non-prescription products.

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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 I for list of Routes of Administration

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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).

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C4:    Diagnosis for use

Provide the indication for which the product was prescribed or used in this particular patient.

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C5:    Event abated after use stopped or dose reduced

If available, this information is particularly useful in the evaluation of a suspected adverse event. In addition to checking the appropriate box, please provide supporting lab tests and dates, if available, in block B6.

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C6:    Lot #

If known, include the lot number(s) with all product problem reports, or any adverse event report with a biologic or medication.

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C7:    Expiration date

Please include if available.

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C8:    Event reappeared after reintroduction

If available, this information is particularly useful in the evaluation of a suspected adverse event. In addition to checking the appropriate box, please provide supporting lab tests and dates, if available, in block B6.

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C9:    NDC #

The national drug code is requested 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.

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C10:  Concomitant medical products and therapy dates

Information on the use of concomitant medical products can frequently provide insight into previously unknown interactions between products, or provide an alternative explanation for the observed adverse event. Please list and provide therapy dates for any other medical products (drugs, biologics, medical devices, etc.) that a patient was using at or around the time of the event. Do not include products used to treat the event.

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SECTION D: SUSPECT MEDICAL DEVICE

The suspect medical device is 1) the device that may have caused or contributed to the adverse event or 2) the device that malfunctioned.

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 which you do not think were involved in the event.

If more than one suspect medical device was involved in the event, complete all of section D for the first device and attach a separate completed section D for each additional device.

If the suspect medical device is a single use device that has been reprocessed, then the reprocessor is now the device manufacturer.

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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. Reprocessed single use devices may bear the Original Equipment Manufacturer (OEM) brand name. If the suspect device is a reprocessed single use device enter "NA".

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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.). Please do not use broad generic terms such as "catheter", "valve", "screw", etc.

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D3:    Manufacturer name & address

If available, list the full name and mailing address of the manufacturer of the suspected medical device. If the answer is Block D8 is "yes", then enter the name and address of the reprocessor.

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D4:    Product identification number/expiration date

If available, provide 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 fund 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 (mo/day/yr): 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 bar-coded product ID, etc.)

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D5:    Operator of device

If available; this date can often be found on the device itself or printed on the accompanying packaging.

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D6:   If implanted, give date (mo/day/yr)

For medical devices that are implanted in the patient, provide the implant date or your best estimate.  If day is unknown, month and year are acceptable. If month and day are unknown, year is acceptable. 

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D7:   If explanted, give date (mo/day/yr)

If an implanted device was removed from the patient, provide the explant date or your best estimate. If day is unknown, month and year are acceptable. If month and day are unknown, year is acceptable.

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D8:   Is this a Single-use Device that was Reprocessed and Reused on a Patient?

Indicate "Yes" or "No".

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D9:  If Yes to Item No.8, Enter Name and Address of Reprocessor:

Enter the name and address of the reprocessor of the single-use device. Anyone who reprocesses single-use devices for reuse in humans is the manufacturer of the reprocessed device.

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D10: Device available for evaluation?

To evaluate a reported problem with a medical device, it is often critical for the manufacturer to be able to examine the suspect product. Thus, please indicate whether the device is available for evaluation.

Indicate if the device was returned to the manufacturer and, if so, the date of the return. Do not send the device to FDA.

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D11: Concomitant medical products and therapy dates

Information on the use of concomitant medical products can frequently provide insight into previously unknown interactions between products, or provide an alternative explanation for the observed adverse event. Please 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.

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SECTION E: INITIAL REPORTER

FDA recognizes that confidentiality is an important concern to health professionals in the context of adverse event reporting. The patient's identity is held in strict confidence by FDA and protected to the fullest extent of the law. However, to allow for timely follow-up in serious cases, the reporter's identity may be shared with the manufacturer unless specifically requested otherwise in block E5. The FDA will not disclose the reporters identity in response to a request from the public, pursuant to the Freedom of Information Act.

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E1:    Name, address & phone #

Please provide the name, mailing address and phone number of the person who can be contacted to provide information on the event if follow-up is necessary. While optional, providing the contact's E-mail address and/or fax number, would be most helpful, if available. This person will also receive an acknowledgment letter from the MedWatch program.

This information is necessary for both adverse event and product problem reports.

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E2:    Health professional?

Please indicate whether you are a health professional (e.g., physician, pharmacist, nurse, etc.) or not. If you are not a health professional, please complete block E3 by filling in NA.

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E3:    Occupation:

Please indicate your occupation (particularly type of health professional), and include specialty, if appropriate.

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E4:    Also reported to

Please indicate whether you have also notified or submitted a copy of this report to the manufacturer and/or distributor of the product, or, in the case of medical device reports only, to the user facility (institution) in which the event occurred. This information helps to track duplicate reports in the FDA database.

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E5:    Release of reporter's identify to the manufacturer

In the case of a serious adverse event (see B1), the Agency may provide name, address and phone number of the reporter denoted in block E1 to the manufacturer of the suspect product. If you do not want your identity released to the manufacturer, please put an X in this box.

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APPENDIX I

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Web page last revised by jlw April 27, 2004