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Manufacturer and User Facility Device Experience Database - (MAUDE)

File Formats for FOI Releasable Data

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)

[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
• 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.

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.

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.

PATIENTxxx.TXT files contains following 4 fields, delimited by pipe (|), one record per line:

FOITEXTxxx.TXT files contains following 6 fields, delimited by pipe (|), one record per line:

Event Location Code Key

Updated October 8, 2004

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