Medical Devices

Manufacturer and User Facility Device Experience Database - (MAUDE)

MAUDE data represents reports of adverse events involving medical devices. The download data files consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. The searchable database data contains the last 10 year's data. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19.

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. MAUDE data is current through the end of the previous month. FDA seeks to include all reports received prior to the update. However, the inclusion of some reports may be delayed by technical or clerical difficulties.

MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.

Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. Searches only retrieve records that contain the search term(s) provided by the requester.

The data is also available in zipped files for downloading. The data is updated on a weekly 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 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 anevent. 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 NameCompressed
Size in Bytes
Uncompressed
Size in Bytes
Total Records 
mdrfoi.zip7124KB78593KB235619MAUDE Base records received to date for 2015
mdrfoiadd.zip2669KB30689KB91702New MAUDE Base records for the current month.
mdrfoichange.zip3664KB38727KB113057MAUDE Base data updates: changes to existing Base data.
mdrfoithru2014.zip147203KB1305907KB4083859Master Record through 2014
patient.zip914KB6499KB235645MAUDE Patient records received to date for 2015
patientadd.zip333KB2464KB91705New MAUDE Patient records for the current month.
patientchange.zip449KB3061KB113003MAUDE Patient data updates: changes to existing Base data.
patientthru2014.zip22427KB141891KB4068429Patient Record through 2014
deviceproblemcodes.zip9KB27KB986Device Data for problemcodes
foidev.zip5967KB48387KB236048Device Data for foidev
foidev1998.zip3205KB17539KB63440Device Data for foidev1998
foidev1999.zip2764KB14798KB52880Device Data for foidev1999
foidev2000.zip2815KB15159KB53293Device Data for foidev2000
foidev2001.zip3040KB16283KB58067Device Data for foidev2001
foidev2002.zip3219KB17264KB65808Device Data for foidev2002
foidev2003.zip3372KB17953KB67844Device Data for foidev2003
foidev2004.zip2897KB14884KB57045Device Data for foidev2004
foidev2005.zip4427KB24661KB93413Device Data for foidev2005
foidev2006.zip6109KB34443KB134516Device Data for foidev2006
foidev2007.zip5602KB31935KB149334Device Data for foidev2007
foidev2008.zip5207KB32883KB164611Device Data for foidev2008
foidev2009.zip7230KB45718KB221478Device Data for foidev2009
foidev2010.zip10580KB68359KB338824Device Data for foidev2010
foidev2011.zip12546KB82774KB415739Device Data for foidev2011
foidev2012.zip15861KB103052KB521772Device Data for foidev2012
foidev2013.zip19041KB127951KB639269Device Data for foidev2013
foidev2014.zip24255KB176278KB869528Device Data for foidev2014
foidevadd.zip2213KB18797KB91831New MAUDE Device data for the current month.
foidevchange.zip3104KB23980KB113639Device data updates: changes to existing Device data and additional Device data for existing Base records.
foidevproblem.zip3305KB22348KB1671177Device Data for foidevproblem
foidevthru1997.zip6001KB31217KB136917Device Data through foidevthru1997
foitext.zip26881KB171180KB455800Narrative Data received to date for 2015
foitext1996.zip3471KB13854KB45320Narrative Data for 1996
foitext1997.zip10020KB43208KB140703Narrative Data for 1997
foitext1998.zip8257KB35948KB105288Narrative Data for 1998
foitext1999.zip7205KB30804KB84968Narrative Data for 1999
foitext2000.zip9055KB38741KB107575Narrative Data for 2000
foitext2001.zip9641KB39950KB114526Narrative Data for 2001
foitext2002.zip10416KB43824KB120528Narrative Data for 2002
foitext2003.zip9996KB43169KB118854Narrative Data for 2003
foitext2004.zip9728KB40855KB96689Narrative Data for 2004
foitext2005.zip15096KB65231KB177109Narrative Data for 2005
foitext2006.zip20554KB90986KB234272Narrative Data for 2006
foitext2007.zip20178KB91196KB237466Narrative Data for 2007
foitext2008.zip20916KB101156KB264918Narrative Data for 2008
foitext2009.zip29653KB147362KB388795Narrative Data for 2009
foitext2010.zip48609KB254523KB697596Narrative Data for 2010
foitext2011.zip69783KB382620KB964931Narrative Data for 2011
foitext2012.zip93248KB505184KB1224583Narrative Data for 2012
foitext2013.zip100883KB549080KB1441268Narrative Data for 2013
foitext2014.zip119817KB668141KB1794464Narrative Data for 2014
foitextadd.zip9978KB66756KB174561New MAUDE Narrative data for the current month.
foitextchange.zip13981KB87486KB235114Narrative data updates: changes to existing narrative data and additional narrative data for existing base records.
foitextthru1995.zip3331KB16780KB27404Narrative data through 1995

[Accessibility]

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
  • Patient dates are in the format DD-MON-YY, and all other 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.

MDRFOI file contains following 75 fields, delimited by pipe (|), one record per line:

1. MDR Report Key
2. Event Key
3. Report Number
4. Report Source Code

P = Voluntary report
U = User Facility report
D = Distributor report
M = Manufacturer report

5. Manufacturer Link Flag (internal information flag)
6. Number Devices in Event (if source code is 'P', field will be null)
7. Number Patient in Event (if source code is 'P', field will be null)
8. Date Received

SECTION-B

9. Adverse Event Flag (B1)
10. Product Problem Flag (B1)
11. Date Report (B4)
12 Date of Event (B3) -- new added, 2006
13 Single Use Flag (Reprocessor Flag) (D8) -- new added, 2006
14 Reporter Occupation Code (E3) -- new added, 2006

* INVALID DATA
000 OTHER
001 PHYSICIAN
002 NURSE
0HP HEALTH PROFESSIONAL
0LP LAY USER/PATIENT
100 OTHER HEALTH CARE PROFESSIONAL
101 AUDIOLOGIST
102 DENTAL HYGIENIST
103 DIETICIAN
104 EMERGENCY MEDICAL TECHNICIAN
105 MEDICAL TECHNOLOGIST
106 NUCLEAR MEDICINE TECHNOLOGIST
107 OCCUPATIONAL THERAPIST
108 PARAMEDIC
109 PHARMACIST
110 PHLEBOTOMIST
111 PHYSICAL THERAPIST
112 PHYSICIAN ASSISTANT
113 RADIOLOGIC TECHNOLOGIST
114 RESPIRATORY THERAPIST
115 SPEECH THERAPIST
116 DENTIST

300 OTHER CAREGIVERS
301 DENTAL ASSISTANT
302 HOME HEALTH AIDE
303 MEDICAL ASSISTANT
304 NURSING ASSISTANT
305 PATIENT
306 PATIENT FAMILY MEMBER OR FRIEND
307 PERSONAL CARE ASSISTANT
400 SERVICE AND TESTING PERSONNEL
401 BIOMEDICAL ENGINEER
402 HOSPITAL SERVICE TECHNICIAN
403 MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
404 PHYSICIST
405 SERVICE PERSONNEL
499 DEVICE UNATTENDED
500 RISK MANAGER
600 ATTORNEY
999 UNKNOWN
NA NOT APPLICABLE
NI NO INFORMATION
UNK UNKNOWN

SECTION-E (if source code is 'P', Section E to H will contain no data)

15. Health Professional (E2)
16. Initial Report to FDA (E4)

Y = Yes
N = No
U = Unknown
* = No answer provided

SECTION-F

17. Distributor Name (F3) -- if report source code = 'M' and
Manufacturer link flag is 'Y', fields 14 - 20 will contain data;
otherwise they will be null
18. Distributor Address line 1 (F3)
19. Distributor Address line 2 (F3)
20. Distributor City (F3)
21. Distributor State Code (F3)
22. Distributor Zip Code (F3)
23. Distributor Zip Code Ext (F3)
24. Date Facility Aware (F6)
25. Type of Report (F7) !multiple submission type, separate by ','

I = Initial submission
F = Followup
X = Extra copy received
O = Other information submitted

26. Report Date (F8)
27. Report to FDA (F11)
28. Date Report to FDA (F11)
29. Event Location (F12)
30. Report to Manufacturer (F13)
31. Date Report to Manufacturer (F13)
32. Manufacturer Name (F14)
33. Manufacturer Address line 1 (F14)
34. Manufacturer Address line 2 (F14)
35. Manufacturer City (F14)
36. Manufacturer State Code (F14)
37. Manufacturer Zip Code (F14)
38. Manufacturer Zip Code Ext (F14)
39. Manufacturer Country Code (F14)
40. Manufacturer Postal Code (F14)

SECTION-G (only for report source 'M', others sources will be null)

41. Manufacturer Contact Title Name (G1)
42. Manufacturer Contact First Name (G1)
43. Manufacturer Contact Last Name (G1)
44. Manufacturer Contact Street 1 (G1)
45. Manufacturer Contact Street 2 (G1)
46. Manufacturer Contact City (G1)
47. Manufacturer Contact State Code (G1)
48. Manufacturer Contact Zip Code (G1)
49. Manufacturer Contact Zip Code Ext (G1)
50. Manufacturer Contact Country Code
51. Manufacturer Contact Postal Code
52. Manufacturer Contact Phone No Area Code (G1)
53. Manufacturer Contact Phone No Exchange (G2)
54. Manufacturer Contact Phone No (G2)
55. Manufacturer Contact Phone No Ext (G2)
56. Manufacturer Contact Phone No Country Code
57. Manufacturer Contact Phone No City Code
58. Manufacturer Contact Phone No Local
59. Manufacturer G1 Name (G1)
60. Manufacturer G1 Street 1 (G1)
61. Manufacturer G1 Street 2 (G1)
62. Manufacturer G1 City (G1)
63. Manufacturer G1 State Code (G1)
64. Manufacturer G1 Zip Code (G1)
65. Manufacturer G1 Zip Code Ext (G1)
66. Manufacturer G1 Country Code
67. Manufacturer G1 Postal Code
68. Source Type (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

69. Date Manufacturer Received (G4)

SECTION-H
70. Device Date Of Manufacture (H4)
71. Single Use Flag (H5)
72. Remedial Action (H7) -- multiple source type, separate by ','

RC = Recall
RP = Repair
RL = Replace
RB = Relabeling
OT = Other
NO = Notification
IN = Inspection
PM = Patient Monitoring
MA = Modification/Adjustment
* = Invalid Data

73. Previous Use Code (H8)
74. Removal/Correction Number (H9)
75. Event type (H1) -- only relevant for report sourcetype 'M'

D = Death
IN = Injury
IL = Injury
IJ = Injury
M = Malfunction
O = Other
* = No answer provided

DEVICE file contains following 45 fields, delimited by pipe (|), one record per line:

1. MDR Report Key
2. Device Event key
3. Implant Flag -- D6, new added; 2006
4. Date Removed Flag -- D7, new added; 2006; if flag in M or Y, print Date

U = Unknown
A = Not available
I = No information at this time
M = Month and year provided only, day defaults to 01
Y = Year provided only, day defaulted to 01, month defaulted to January

5. Device Sequence No -- from device report table
6. Date Received (from mdr_document table)

SECTION-D

7. Brand Name (D1)
8. Generic Name (D2)
9. Manufacturer Name (D3)
10. Manufacturer Address 1 (D3)
11. Manufacturer Address 2 (D3)
12. Manufacturer City (D3)
13. Manufacturer State Code (D3)
14. Manufacturer Zip Code (D3)
15. Manufacturer Zip Code ext (D3)
16. Manufacturer Country Code (D3)
17. Manufacturer Postal Code (D3)
18. Expiration Date of Device (D4)
19. Model Number (D4)
20. Lot Number (D4)
21. Catalog Number (D4)
22. Other ID Number (D4)
23. Device Operator (D5)
24. Device Availability (D10)

Y = Yes
N = No
R = Device was returned to manufacturer
* = No answer provided

25. Date Returned to Manufacturer (D10)
26. Device Report Product Code
27. Device Age (F9)
28. Device Evaluated by Manufacturer (H3)

Y = Yes
N = No
R = Device not returned to manufacturer
* = No answer provided

BASELINE SECTION

29. Baseline brand name
30. Baseline generic name
31. Baseline model no
32. Baseline catalog no
33. Baseline other id no
34. Baseline device family
35. Baseline shelf life contained in label

Y = Yes
N = No
A = Not applicable
* = No answer provided

36. Baseline shelf life in months
37. Baseline PMA flag
38. Baseline PMA no
39. Baseline 510(k) flag
40. Baseline 510(k) no
41. Baseline preamendment
42. Baseline transitional
43. Baseline 510(k exempt flag
44. Baseline date) first marketed
45. Baseline date ceased marketing

PATIENT file contains following 5 fields, delimited by pipe (|), one record per line:

1. MDR Report Key (from patient report table)
2. Patient Sequence Number (from patient report table)
3. Date Received (from mdr_document table)
4. Sequence Number||','|| Treatment -- multiple source type, separate by ';'
5. Sequence Number||','|| Outcome -- multiple source type, separate by ';'

L - Life Threatening
H - Hospitalization
S - Disability
C - Congenital Anomaly
R - Required Intervention
O - Other
* - Invalid Data
U - Unknown
I - No Information
A - Not Applicable
D - Death

TEXT file contains following 6 fields, delimited by pipe (|), one record per line:

1. MDR Report Key
2. MDR Text Key
3. Text Type Code (D=B5, E=H3, N=H10 from mdr_text table)
4. Patient Sequence Number (from mdr_text table)
5. Date Report (from mdr_text table)
6. Text (B5, or H3 or H10 from mdr_text table)

FOIDEVPROBLEM contains following 2 fields, delimited by pipe (|), one record per line:

1. MDR Report Key
2. Device Problem Code -- (F10) new added; 2006

DEVICEPROBLEMCODES contains following 2 fields, delimited by pipe (|),
one record per line:

1. Device Problem Code
2. Problem Description

Device Operator Code Key

* INVALID DATA
0 OTHER
1 PHYSICIAN
2 NURSE
0HP HEALTH PROFESSIONAL
0LP LAY USER/PATIENT
100 OTHER HEALTH CARE PROFESSIONAL
101 AUDIOLOGIST
102 DENTAL HYGIENIST
103 DIETICIAN
104 EMERGENCY MEDICAL TECHNICIAN
105 MEDICAL TECHNOLOGIST
106 NUCLEAR MEDICINE TECHNOLOGIST
107 OCCUPATIONAL THERAPIST
108 PARAMEDIC
109 PHARMACIST
110 PHLEBOTOMIST
111 PHYSICAL THERAPIST
112 PHYSICIAN ASSISTANT
113 RADIOLOGIC TECHNOLOGIST
114 RESPIRATORY THERAPIST
115 SPEECH THERAPIST
116 DENTIST

300 OTHER CAREGIVERS
301 DENTAL ASSISTANT
302 HOME HEALTH AIDE
303 MEDICAL ASSISTANT
304 NURSING ASSISTANT
305 PATIENT
306 PATIENT FAMILY MEMBER OR FRIEND
307 PERSONAL CARE ASSISTANT
400 SERVICE AND TESTING PERSONNEL
401 BIOMEDICAL ENGINEER
402 HOSPITAL SERVICE TECHNICIAN
403 MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
404 PHYSICIST
405 SERVICE PERSONNEL
499 DEVICE UNATTENDED
500 RISK MANAGER
600 ATTORNEY
999 UNKNOWN
NA NOT APPLICABLE
NI NO INFORMATION
UNK UNKNOWN

Event Location Code Key

* 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

 

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