Manufacturer and User Facility Device Experience Database - (MAUDE)

File Formats arcfor FOI Releasable Data

MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. 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 is scheduled to be updated quarterly and the search page reflects the date of the most recent update. 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 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 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 Name	Compressed Size in Bytes	Uncompressed Size in Bytes	Total Records
MDRFOI.ZIP	5795KB	44417KB	155920	MAUDE Base records received to date for 2009
MDRFOIADD.ZIP	533KB	3832KB	13309	New MAUDE Base records for the current month.
MDRFOICHANGE.ZIP	635KB	4433KB	15314	MAUDE Base data updates: changes to existing Base data.
MDRFOITHRU2008.ZIP	40410KB	270669KB	1048501	Master Record through 2008
PATIENT.ZIP	1199KB	6468KB	156703	MAUDE Patient Records received to date for 2009
PATIENTADD.ZIP	110KB	597KB	13335	New MAUDE Patient data for the current month.
PATIENTCHANGE.ZIP	136KB	715KB	15128	Maude Patient data updates: changes to existing Patient data and additional Patient data for existing Base records.
PATIENTTHRU2008.ZIP	7198KB	36806KB	1052370	MAUDE Patient Records through 2008
DEVICEPROBLEMCODES.ZIP	10KB	27KB	975	Device Problem Codes
FOIDEV2000.ZIP	2943KB	15161KB	53298	Device Data for 2000
FOIDEV2001.ZIP	3175KB	16284KB	58071	Device Data for 2001
FOIDEV2002.ZIP	3365KB	17265KB	65810	Device Data for 2002
FOIDEV2003.ZIP	3526KB	17953KB	67843	Device Data for 2003
FOIDEV2004.ZIP	3024KB	14887KB	57056	Device Data for 2004
FOIDEV2005.ZIP	4624KB	24668KB	93436	Device Data for 2005
FOIDEV2006.ZIP	6292KB	33934KB	132453	Device Data for 2006
FOIDEV2007.ZIP	5393KB	27419KB	132313	Device Data for 2007
FOIDEV2008.ZIP	5032KB	27620KB	145788	Device Data for 2008
FOIDEV98.ZIP	3314KB	17338KB	62743	Device Data for 1998
FOIDEV99.ZIP	2834KB	14522KB	51877	Device Data for 1999
FOIDEV.ZIP	5535KB	30741KB	156924	Device Data received to date for 2009
FOIDEVPROBLEM.ZIP	2038KB	9338KB	714823	Device Problem Codes
FOIDEVTHRU97.ZIP	6278KB	31216KB	136916	Device Data through 1997
FOITEXT2000A.ZIP	4735KB	19496KB	54514	Narrative Data for January through June 2000
FOITEXT2000B.ZIP	4785KB	19262KB	53056	Narrative Data for July through December 2000
FOITEXT2001A.ZIP	4957KB	19443KB	56831	Narrative Data for January through June 2001
FOITEXT2001B.ZIP	5184KB	20519KB	57694	Narrative Data for July through December 2001
FOITEXT2002A.ZIP	5530KB	22002KB	60293	Narrative Data for January through June 2002
FOITEXT2002B.ZIP	5423KB	21832KB	60220	Narrative Data for July through December 2002
FOITEXT2003A.ZIP	5066KB	21202KB	59472	Narrative Data for January through June 2003
FOITEXT2003B.ZIP	5443KB	21965KB	59367	Narrative Data for July through December 2003
FOITEXT2004A.ZIP	4802KB	19116KB	46473	Narrative Data for January through June 2004
FOITEXT2004B.ZIP	5431KB	21730KB	50187	Narrative Data for July through December 2004
FOITEXT2005A.ZIP	9078KB	36757KB	101415	Narrative Data for January through June 2005
FOITEXT2005B.ZIP	6790KB	28423KB	75502	Narrative Data for July through December 2005
FOITEXT2006A.ZIP	10969KB	45806KB	124320	Narrative Data for January through June 2006
FOITEXT2006B.ZIP	10393KB	44233KB	107239	Narrative Data for July through December 2006
FOITEXT2007A.ZIP	9584KB	40586KB	103310	Narrative Data for January through June 2007
FOITEXT2007B.ZIP	11341KB	49453KB	131230	Narrative Data for July through December 2007
FOITEXT2008A.ZIP	33177KB	152251KB	742334	Narrative Data for January through June 2008
FOITEXT2008B.ZIP	1455KB	6923KB	319830	Narrative Data for July through December 2008
FOITEXT.ZIP	7963KB	36017KB	295051	Narrative Data received to date for 2009
FOITEXT96.ZIP	3646KB	13858KB	45320	Narrative Data for 1996
FOITEXT97A.ZIP	5399KB	21957KB	73047	Narrative Data for January through June 1997
FOITEXT97B.ZIP	5117KB	21292KB	67659	Narrative Data for July through December 1997
FOITEXT98A.ZIP	4926KB	20903KB	60286	Narrative Data for January through June 1998
FOITEXT98B.ZIP	3701KB	14906KB	44514	Narrative Data for July through December 1998
FOITEXT99A.ZIP	3500KB	13947KB	38268	Narrative Data for January through June 1999
FOITEXT99B.ZIP	4025KB	16727KB	46171	Narrative Data for July through December 1999

[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

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
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. Device Operator (D4)
19. Expiration Date of Device (D5)
20. Model Number (D6)
21. Catalog Number (D6)
22. Lot Number (D6)
23. Other ID Number (D6)
24. Device Availability (D9)

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

25. Date Returned to Manufacturer (D9)
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

Event Location Code Key