The FDA MAUDE database is a set of officially maintained databases for medical device records, organized by year, after adverse events to patients are identified. The set of databases are publicly available, and can be downloaded as zipped text files. The databases are organized on a yearly basis, dating back as early as to 1996. The databases contain rich amount of information with regard to adverse events caused by medical devices.
In this post, I will explain from where each piece of information on a given search result page is from. To do this, I made a screenshot of a webpage of an example search result. The relevant information for this single page is drawn from the following databases, with the particular records picked out. (Notice that the example is an event in 2010, so the specific database is used.)
foidev2010.txt(45 fields per record):
1702514|1745823|N|B|1|05/28/2010|COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH|PUMP, INFUSION|BAXTER HEALTHCARE - SINGAPORE|2 WOODLANDS INDUSTRIAL PARK||SINGAPORE||||SN|2573|||DNM8151|||0|R|07/19/2010|FRN|DA|R|||||||||||||||||
foitext2010.txt(6 fields per record, possibly multiple records per event):
1702514|9317419|N|1||A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S.THE BAXTER FIELD SERVICE TECHNICIAN REPAIRED THE DEVICE ON SITE. AS SUCH, THE DEVICE WILL NOT BE RETURNED TO CANADIAN TECHNICAL SERVICES. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.
1702514|9317416|D|1||ON MAY 7 2010, THE BAXTER FIELD SERVICE TECHNICIAN ADVISED THAT A COLLEAGUE DEVICE, PRODUCT CODE DNM8151, (B)(4) WAS SERVICED FOR A DAMAGED PHM (PUMP HEAD MODULE) KEYPAD. THE STOP KEY WAS NOT FUNCTIONING. THE DATE OF INCIDENT AND THE PROCESS STEP ARE UNKNOWN. PATIENT INJURY/MEDICAL INTERVENTION WAS NOT REPORTED TO HAVE OCCURRED. THE BAXTER FIELD SERVICE TECHNICIAN REPAIRED THE DEVICE ON SITE. AS SUCH, THE DEVICE WILL NOT BE RETURNED TO CANADIAN TECHNICAL SERVICES.
mdrfoiThru2012.txt(75 fields per record):
1702514|1616667|6000001-2010-00604|M|Y|1|1|05/28/2010|N|Y|05/07/2010|05/01/2010|N|401|Y|N|||||||||I|||||N||BAXTER HEALTHCARE - SINGAPORE|2 WOODLANDS INDUSTRIAL PARK||SINGAPORE||||SN|2573||KAREN|KIRBY|25212 W. ILLINOIS ROUTE 120||ROUND LAKE|IL|60073||US||847|270|4541|||||BAXTER HEALTHCARE - SINGAPORE|2 WOODLANDS INDUSTRIAL PARK||SINGAPORE||||SN|2573|01,05|07/20/2010||N||R||M
patientThru2012.txt(5 fields per record):
Notice that the fields are separated by vertical bars
|. The explanations of each field can be found in the DEVICE, TEXT, MDRFOI, and PATIENT sections on the database file download page. The distinction between the two entries (for the same event) in
foitext2010.txt is that, in the first, the Text Type Code (Field #3) is
N, and in the second, it is
D. They refer to the entries in the following fields of a MEDWATCH 3500/3500A forms, as follows.
- D = B5: Description of Event or Problem
- N = H10: Additional Manufacturer Narrative
- Page Heading. This is composed of fields #9, 7 and 8 of the record in
- Table Heading. The same as Page Heading, with spaces inserted properly.
- Catalog Number. The 20th field of the record in
foitext2010.txt. It is not clear what this means.
- Event Date. Field #12 of
- Event Type. Field #75 of
- D = Death
- IN = Injury
- IL = Injury
- IJ = Injury
- M = Malfunction
- O = Other
- = No answer provided
- Manufacturer Narrative. Field #6 of
foitext2010.txt, if Field #3 is
- Event Description. Field #6 of
foitext2010.txt, if Field #3 is
- Brand Name. Field #7 of
- Type of Device. Field #8 of
- Manufacturer (Section F). Fields #32–40 of
- Manufacturer (Section D). Fields #9–17 of
- Manufacturer (Section G). Probably the same as Manufacturer (Section F)?
- Manufacturer Contact. Fields #41–67 of
- Device Event Key. Field #2 of
foidev2010.txt. It is not clear what this means.
- MDR Report Key. Field #1 of every related record. This is the key to relate all the records.
- Event Key. Field #2 of
- Report Number. Field #3 of
- Device Sequence Number. Field #5 of
- Product Code. Field #26 of
foidev2010.txt. It contains uppercase letter codes for different product classes. I produced a mapping from the device code to the product class, both in alphabetical order of product classes and in alphabetical order of the letter codes, based on the information from the source code of the search page.
- Report Source. Field #4 of
- P = Voluntary report
- U = User Facility report
- D = Distributor report
- M = Manufacturer report
- Source Type. Field #68 of
mdrfoiThru2012.txt. 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
- Reporter Occupation. Field #14 of
mdrfoiThru2012.txt. See the table Device Operator Code Key on the download page for details.
- Type of Report. Field #25 of
mdrfoiThru2012.txt. Multiple submission type, separate by ‘,’
- I = Initial submission
- F = Followup
- X = Extra copy received
- O = Other information submitted
- Report Date. Field #11 of
- # Device Was Involved in the Event. Field #6 of
- # Patient Was Involved in the Event. Field #7 of
- Date FDA Received. Field #8 of
- Is This An Adverse Event Report? Field #9 of
- Is This A Product Problem Report? Field #10 of
- Device Operator. Field #23 of
- Device Catalogue Number. Field #21 of
- Was Device Available For Evaluation? Field #24 of
- Y = Yes
- N = No
- R = Device was returned to manufacturer
- = No answer provided
- Date Returned to Manufacturer. Field #25 of
- Is The Reporter A Health Professional? Field #15 of
- Was The Report Sent To Manufacturer? Field #30 of
- Date Manufacturer Received. Field #31 of
- Was Device Evaluated By Manufacturer? Field #28 of
- Is The Device Single Use? Field #71 of
- Is this a Reprocessed and Reused Single-Use Device? Field #13 of
- Is the Device an Implant? Field #3 of
- Is this an Explanted Device? It is not clear what this means. Maybe the opposite of implant?
- Type of Device Usage. Field #73 of
mdrfoiThru2012.txt, corresponding to Field H8 of the MEDWATCH 3500/3500A forms, with possible values of initial use, reuse, or unknown. (In the example, it is
With the information above, it is easier for me to perform some detailed research on events recorded in the MAUDE databases, which I will show in the next post.