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MAUDE data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June, 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August, 1996.
An on-line search is available which allows you to search the CDRH's database information on medical devices which may have malfunctioned or caused a death or serious injury.
The data is also available in zipped files for downloading. The data is updated on a quarterly basis.
These files were then compressed ("zipped") in order to save space. For these files to be useful to you, you'll first have to download them, unzip them, and then import them into a database or word processor for your further processing.
DISCLAIMER: Section 21 CFR 803.16 states that "A report or other information submitted by a reporting entity under this part, and any release by FDA of that report or information, does not necessarily reflect a conclusion by the party submitting the report or by FDA that the report or information constitutes an admission that the device, or the reporting entity or its employees, caused or contributed to the reportable event. The reporting entity need not admit and may deny that the report or information submitted under this part constitutes an admission that the device, the party submitting the report, or employees thereof, caused or contributed to a reportable event." In addition, some firms have submitted their own additional disclaimer statements. A file of those disclaimers will be placed on the web shortly.
The releasable MAUDE data is presented in four logical records types. For this data to be meaningful, you should download all four types of files. The four record formats contain all releasable information on MEDWATCH Form 3500A and 3500.
Downloading Hint: When downloading the MAUDE data files to a database such as Microsoft Access, it is recommended that you first open, then save the data file in Microsoft WORD. This will add an "end of record" marker to each MAUDE record that can be recognized by Microsoft ACCESS. For files such as the FOIDEV files, you may need to put in an extra character at the end of the first record prior to importing the file, otherwise the last column of data may be lost.
Master Event Data: A distinct master event data record will be present for each source reporting an event. In other words, if a User Facility, Distributor, Manufacturer, and voluntary submitter all report an event, there will be four event records. These individual source records are related via the EVENT KEY. EVENT KEY is an internally-generated key which links multiple sources to a single event.
Device Data: Record Type 2 contains information related to the device(s) involved in the event.
Patient Data: Record Type 3 contains information related to the patient(s) involved in the event.
Text Data: Record Type 4 contains textual information from MEDWATCH Form Sections B5, H3, and H10.
All record types are linked via the MDR REPORT KEY.
For distributor reports which have had subsequent manufacturer reports, a special data element, MANUFACTURER LINK FLAG, will be set to 'Y'. In this case, the DISTRIBUTOR information (Section F on the master event data record) will be present; otherwise, these data elements will be blank.
The following files are available: (File Sizes are approximate)
File Name | Compressed Size in Bytes |
Uncompressed Size in Bytes |
Total Records | |
---|---|---|---|---|
MDRFOICHANGE.ZIP | 1210 KB | 8,160 KB | 27,339 | MAUDE Base data updates: changes to existing Base data. |
MDRFOITHRU2003.ZIP | 19, 646 KB | 138,562 KB | 493,816 | Master Record through 2003 |
MDRFOIADD.ZIP | 586 KB | 4,008 KB | 13,578 | New MAUDE Base records for the current quarter. |
MDRFOI.ZIP | 1737 KB | 11,849 KB | 40,616 | MAUDE Base records for first 3 quarters of 2004 |
PATIENTCHANGE.ZIP | 235 KB | 1,140 KB | 27,382 | MAUDE Patient data updates: changes to existing Patient data and additional Patient data for existing Base records. |
PATIENTTHRU2003.ZIP | 3,475 KB | 17,486 KB | 495,782 | MAUDE Patient Record through 2003 |
PATIENTADD.ZIP | 120 KB | 601 KB | 13,607 | New MAUDE Patient data for the current quarter. |
PATIENT.ZIP | 330 KB | 1,630 KB | 40,676 | Patient data for the first 3 quarters of 2004 |
FOIDEV2003.ZIP | 3,468 KB | 17,642 KB | 67,851 | Device data for 2003. |
FOIDEV2002.ZIP | 3320 KB | 17,007 KB | 65,813 | Device data for 2002 |
FOIDEV2001.ZIP | 3135 KB | 16,057 KB | 58,074 | Device data for 2001 |
FOIDEVCHANGE.ZIP | 1,447 KB | 7,290 KB | 27,685 | Device data updates: changes to existing Device data and additional Device data for existing Base records. |
FOIDEV2000.ZIP | 2,907 KB | 14,961 KB | 53,299 | Device data for 2000 |
FOIDEVTHRU97.ZIP | 6,216 KB | 30,750 KB | 136,917 | Device Data through 1997 |
FOIDEV98.ZIP | 3,309 KB | 17,307 KB | 63,444 | Device Data for 1998 |
FOIDEV99.ZIP | 2,852 KB | 14,602 KB | 52,882 | Device Data for 1999 |
FOIDEVADD.ZIP | 710 KB | 3,600 KB | 13,762 | New MAUDE Device data for the current quarter. |
FOIDEV.ZIP | 2,126 KB | 10,643 KB | 41,410 | MAUDE Device Data for the first 3 quarters of 2004 |
FOITEXT2003A.ZIP | 4,985 KB | 20,865 KB | 59,723 | MAUDE Narrative data for January - June 2003 |
FOITEXT2003B.ZIP | 5,408 KB | 21,811 KB | 59,715 | MAUDE Narrative data for July-December 2003 |
FOITEXT2002A.ZIP | 5,509 KB | 21,852 KB | 60,951 | MAUDE Narrative data for January-June 2002 |
FOITEXT2002B.ZIP | 5,386 KB | 21,625 KB | 60,893 | MAUDE Narrative data for the July-December 2002 |
FOITEXT2001A.ZIP | 4,949 KB | 19,383 KB | 57,249 | MAUDE Narrative data for January-June 2001 |
FOITEXT2001B.ZIP | 5,174 KB | 20,459 KB | 58,114 | MAUDE Narrative data for the July-December 2001 |
FOITEXTCHANGE.ZIP | 5,333 KB | 21,144 KB | 51,101 | MAUDE Narrative data updates: changes to existing Narrative data and additional Narrative data for existing Base records. |
FOITEXTADD.ZIP | 2,461 KB | 9,960 KB | 23,667 | New MAUDE Narrative data for the current quarter. |
FOITEXT2000A.ZIP | 4,728 KB | 19,445 KB | 54,764 | Narrative Data for January through June 2000 |
FOITEXT2000B.ZIP | 4,780 KB | 19,216 KB | 53,362 | Narrative Data for July through December 2000 |
FOITEXT99A.ZIP | 4,666 KB | 19,066 KB | 52,927 | Narrative Data for January through June 1999 |
FOITEXT99B.ZIP | 4,938 KB | 20,930 KB | 57,679 | Narrative Data for June through December 1999 |
FOITEXT98A.ZIP | 5,265 KB | 23,005 KB | 68,699 | Narrative Data for January through June 1998 |
FOITEXT98B.ZIP | 5,067 KB | 21,132 KB | 62,945 | Narrative Data for July through December 1998 |
FOITEXT97A.ZIP | 5,739 KB | 23,833 KB |
81,300 | Narrative Data for January through June 1997 |
FOITEXT97B.ZIP | 5,467 KB | 23,461 KB | 76,827 | Narrative Data for July through December 1997 |
FOITEXT96.ZIP | 3,869 KB | 14,960 KB | 49,923 | Narrative Data for 1996 |
FOITEXTTHRU95.ZIP | 3,552 KB | 16,957 KB | 27,706 | Narrative Data up through 1995 |
FOITEXT.ZIP | 7,189 KB | 28,755 KB | 70,082 | Narrative Data for the first 3 quarters of 2004 |
Note: This documentation is intended to be used in conjunction with a copy of Medwatch Form 3500A and 3500.
Record/Data Characteristics:
- The data has one record per line, with the data fields in a pipe-delimited, (i.e., "|") format
- All dates are in the format MM-DD-YYYY.
- All data elements are alpha-numeric
- All text fields contain whatever data was provided/entered. If no information was provided/entered the field will be left empty. If an asterisk ("*") is present, it represents what was entered on the 3500/3500A.
- All "FLAG" data elements have the value of "Y" for Yes, "N" for No, or are blank if no data was available/entered.
- All fields identified as multiply-occurring represent data elements which may have multiple values. Each value will be present in the field, separated by a comma. The word "OTHER" may appear as one of the values if the "Other" box was checked off. If the whole field is blank, no data was reported/entered.
- Section G CONTACT address information may not necessarily be the address where the device is manufactured.
Special Note for REPORT NUMBER data element:
The REPORT NUMBER data element represents Manufacturer Report Number, Distributor Report Number, or internally-generated voluntary report number, depending on the source of the record.
This REPORT NUMBER field will be blank when:
- User Facility submitted the report
- Distributor report has not been followed by a subsequent Manufacturer report.
Special Notes for Voluntary Reports and User Facility Malfunction Reports:
The only data elements which will be present on the Master Event Record will be:
- NEW RECORD
- DEVICE EVENT KEY
- REPORT SOURCE CODE
- MDR REPORT KEY
- EVENT KEY
- Section B
All other data elements will be blank.
MDRxxx.TXT files contains following 72 fields, delimited by pipe (|), one record per line: | |||
Field Position | Maximum Length | Related Area on Medwatch Form | Code Translation |
---|---|---|---|
1. MDR Report Key |
10 | ||
2. Event Key | 10 | ||
3. Report Number | 22 | ||
4. Report Source Code | 1 | P = Voluntary report U = User Facility report D = Distributor report M = Manufacturer report |
|
5. Manufacturer Link Flag | 1 | (internal information flag) | |
6. Number Devices in Event | 5 | (if source code is 'P', field will be null) | |
7. Number Patient in Event | 5 | (if source code is 'P', field will be null) | |
8. Date Received | 11 | ||
SECTION-B | |||
9. Adverse Event Flag | 1 | (B1) | |
10. Product Problem Flag | 1 | (B1) | |
11. Date Report | 11 | (B4) | |
SECTION-E (if source code is 'P', Section E to H will contain no data) | |||
12. Health Professional | 1 | (E2) | Y/N |
13. Initial Report to FDA | 1 | (E4) | Y = Yes N = No U = Unknown * = No answer provided |
SECTION-F | |||
14. Distributor Name | 80 | (F3) if report source code = 'D' and Manufacturer link flag is 'Y', fields 14 - 20 will contain data; otherwise they will be null | |
15. Distributor Address | 30 | (F3) | |
16. Distributor Address | 30 | (F3) | |
17. Distributor City | 30 | (F3) | |
18. Distributor State Code | 2 | (F3) | |
19. Distributor Zip Code | 5 | (F3) | |
20. Distributor Zip Code Ext | 4 | (F3) | |
21. Date Facility Aware | 11 | (F6) | |
22. Type of Report | 1 | (F7) !multiple submission type, separate by ',' | I = Initial submission F = Followup X = Extra copy received O = Other information submitted |
23. Report Date | 11 | (F8) | |
24. Report to FDA | 1 | (F11) | Y/N |
25. Date Report to FDA | 11 | (F11) | |
26. Event Location | 40 | (F12) | (See Event Location Key) |
27. Report to Manufacturer | 1 | (F13) | Y/N |
28. Date Report to Manufacturer | 11 | (F13) | |
29. Manufacturer Name | 80 | (F14) | |
30. Manufacturer Address | 30 | (F14) | |
31. Manufacturer Address | 30 | (F14) | |
32. Manufacturer City | 30 | (F14) | |
33. Manufacturer State Code | 2 | (F14) | |
34. Manufacturer Zip Code | 5 | (F14) | |
35. Manufacturer Zip Code Ext | 4 | (F14) | |
36. Manufacturer Country Code | 2 | (F14) | |
37. Manufacturer Postal Code | 10 | (F14) | |
SECTION-G (only for report source 'M', others sources will be null) | |||
38. Manufacturer Contact Title Name | 4 | (G1) | |
39. Manufacturer Contact First Name | 15 | (G1) | |
40. Manufacturer Contact Last Name | 25 | (G1) | |
41. Manufacturer Contact Street 1 | 30 | (G1) | |
42. Manufacturer Contact Street 2 | 30 | (G1) | |
43. Manufacturer Contact City | 60 | (G1) | |
44. Manufacturer Contact State Code | (G1) | ||
45. Manufacturer Contact Zip Code | 5 | (G1) | |
46. Manufacturer Contact Zip Code Ext | 4 | (G1) | |
47. Manufacturer Contact Country Code | 2 | ||
48. Manufacturer Contact Postal Code | 10 | ||
49. Manufacturer Contact Phone No Area Code | 3 | (G1) | |
50. Manufacturer Contact Phone No Exchange | 3 | (G2) | |
51. Manufacturer Contact Phone No | 4 | (G2) | |
52. Manufacturer Contact Phone No Ext | 5 | (G2) | |
53. Manufacturer Contact Phone No Country Code | 3 | ||
54. Manufacturer Contact Phone No City Code | 3 | ||
55. Manufacturer Contact Phone No Local | 10 | ||
56. Manufacturer G1 Name | 80 | (G1) | |
57. Manufacturer G1 Street 1 | 30 | (G1) | |
58. Manufacturer G1 Street 2 | 30 | (G1) | |
59. Manufacturer G1 City | 30 | (G1) | |
60. Manufacturer G1 State Code | 2 | (G1) | |
61. Manufacturer G1 Zip Code | 5 | (G1) | |
62. Manufacturer G1 Zip Code Ext | 4 | (G1) | |
63. Manufacturer G1 Country Code | 2 | ||
64. Manufacturer G1 Postal Code | 10 | ||
65. Source Type | 30 | (G3) -- multiple source type, separate by ',' | 00 Other 01 Foreign 02 Study 03 Literature 04 Consumer 05 Health Professional 06 User facility 07 Company representation 08 Distributor 99 Unknown * Invalid data |
66. Date Manufacturer Received | 11 | (G4) | |
SECTION-H | |||
67. Device Date of Manufacture | 10 | (H4) | |
68. Single Use Flag | 1 | (H5) | |
69. Remedial Action | 2 | (H7) (multiple source type separated by ',') | RC = Recall RP = Repair RL = Replace RB = Relabeling OT = Other NO = Notification IN = Inspection PM = Patient Monitoring MA = Modification/Adjustment * = Invalid Data |
70. Previous Use Code | 1 | (H8) | |
71. Removal/Correction Number | 24 | (H9) | |
72. Event type | 15 | (H1) -- only relevant for report sourcetype 'M' | D = Death IN = Injury IL = Injury IJ = Injury M = Malfunction O = Other * = No answer provided |
FOIDEVxxx.TXT files contains following 43 fields, delimited by pipe (|), one record per line: | |||
1. MDR Report Key | 10 | ||
2. Device Event key | 10 | ||
3. Device Sequence No | 5 | ||
4. Date Received | 11 | ||
SECTION-D | |||
5. Brand Name | 80 | (D1) | |
6. Generic Name | 80 | (D2) | |
7. Manufacturer Name | 80 | (D3) | |
8. Manufacturer Address 1 | 30 | (D3) | |
9. Manufacturer Address 2 | 30 | (D3) | |
10. Manufacturer City | 30 | (D3) | |
11. Manufacturer State Code | 2 | (D3) | |
12. Manufacturer Zip Code | 5 | (D3) | |
13. Manufacturer Zip Code ext | 4 | (D3) | |
14. Manufacturer Country Code | 2 | (D3) | |
15. Manufacturer Postal Code | 10 | (D3) | |
16. Device Operator | 60 | (D4) | |
17. Expiration Date of Device | 11 | (D5) | |
18. Model Number | 30 | (D6) | |
19. Catalog Number | 30 | (D6) | |
20. Lot Number | 30 | (D6) | |
21. Other ID Number | 30 | (D6) | |
22. Device Availability | 1 | (D9) | Y = Yes N = No R = Device was returned to manufacturer * = No answer provided |
23. Date Returned to Manufacturer | 11 | (D9) | |
24. Device Report Product Code | 3 | ||
25. Device Age | 10 | (F9) | |
26. Device Evaluated by Manufacturer | 1 | (H3) | Y = Yes N = No R = Device not returned to manufacturer * = No answer provided
|
BASELINE SECTION | |||
27. Baseline brand name |
80 | ||
28. Baseline generic name | 80 | ||
29. Baseline model no | 80 | ||
30. Baseline catalog no | 80 | ||
31. Baseline other id no | 80 | ||
32. Baseline device family | 80 | ||
33. Baseline shelf life contained in label | 1 | Y = Yes N = No A = Not applicable * = No answer provided |
|
34. Baseline shelf life in months | 2 | ||
35. Baseline PMA flag | 1 | Y/N | |
36. Baseline PMA no | 12 | ||
37. Baseline 510(k) flag | 1 | Y/N | |
38. Baseline 510(k) no | 12 | ||
39. Baseline preamendment | 1 | Y/N | |
40. Baseline transitional | 1 | Y/N | |
41. Baseline 510(k) exempt flag | 1 | Y/N | |
42. Baseline date first marketed | 11 | ||
43. Baseline date ceased marketing | 11 |
PATIENTxxx.TXT files contains following 4 fields, delimited by pipe (|), one record per line:
Maximum Length |
|
---|---|
1. MDR Report Key |
10 |
2. Patient Sequence Number | 10 |
3. Date Received | 11 |
4. Sequence Number||','|| Treatment The "," is used to concatenate sequence number and treatment. | 5 |
5. Patient Outcome. ||','|| | 5
L - Life Threatening |
FOITEXTxxx.TXT files contains following 6 fields, delimited by pipe (|), one record per line:
Maximum Length |
|
---|---|
1. MDR Report Key |
10 |
2. MDR Text Key | 10 |
3. Text Type Code (D=B5, E=H3, N=H10) | 1 |
4. Patient Sequence Number | 5 |
5. Date Report | 11 |
6. Text (B5, or H3 or H10) | 6000 |
* INVALID
DATA
000 OTHER 001 HOSPITAL 002 HOME 003 NURSING HOME 004 OUTPATIENT TREATMENT FACILITY 005 OUTPATIENT DIAGNOSTIC FACILITY 006 AMBULATORY SURGICAL FACILITY 500 HOSPITAL 501 CATHETERIZATION SUITE 502 CRITICAL CARE UNIT 503 DIALYSIS UNIT 504 EMERGENCY ROOM 505 EXAMINATION ROOM 506 LABORATORY/PATHOLOGY DEPARTMENT 507 MATERNITY WARD - NURSERY 508 OPERATING ROOM 509 OUTPATIENT CLINIC/SURGERY 510 PATIENT'S ROOM OR WARD 511 RADIOLOGY DEPARTMENT 600 AMBULATORY HEALTH CARE FACILITY 601 AMBULATORY SURGICAL CENTER 602 BLOOD BANK 603 BLOODMOBILE 604 CATHETERIZATION LAB - FREE STANDING 605 CHEMOTHERAPY CENTER 606 CLINIC - WALK IN, OTHER 607 DIALYSIS CENTER 608 DRUG CLINIC |
609 IMAGING
CENTER - MOBILE
610 IMAGING CENTER - STATIONARY 611 LABORATORY 612 MOBILE HEALTH UNIT 613 MRI CENTERS 614 PSYCHIATRIC CENTER - WALK IN, OTHER 615 TUBERCULOSIS CLINIC 616 URGENT CARE CENTER 617 OUTPATIENT DIAGNOSTIC FACILITY 700 LONG-TERM CARE FACILITY 701 HOSPICE 702 NURSING HOME 703 PSYCHIATRIC FACILITY 704 REHABILITATION CENTER 705 RETIREMENT HOME 810 PATIENT'S HOME 820 IN TRANSIT TO USER/MEDICAL FACILITY 830 PUBLIC VENUE 831 OUTDOORS 832 PARK 833 PLAYGROUND 834 PUBLIC BUILDING 835 SCHOOL 836 STREET 999 UNKNOWN NA NOT APPLICABLE NI NO INFORMATION UNK UNKNOWN |
Updated October 8, 2004
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