Medical Device Reports (MAUDE)


Source U.S. Food and Drug Administration
File Size 5 GB
Dates Covered 1991 – June 2013 (contact NICAR for archived data to 1984)
Cost Snapshot

  • Nonmembers $300
  • Members $100
Categories: ,


The MAUDE dataset includes information about problems that occurred with medical devices, including injuries, deaths and/or product malfunctions.The data comes from two forms: Medwatch 3500 and 3500A. Health officials use form 3500 to voluntarily report adverse events. User facilities (hospitals, clinics, etc.) as well as product distributors and manufacturers are required to report problems; they use Medwatch 3500A.

Please note that the data do not include patient-specific information (which has been removed for privacy reasons) or geographic information.

The files are in CSV format. If you plan to use Microsoft Access to analyze the data, you must link to, rather than import, the tables.

Record layouts and samples of this database

Data sample (maudesample.xls) 116.8 KB
Schema (maude.pdf) 298.7 KB
Main documentation (maude_readme.txt) 16.0 KB
Record layout (MAUDElay.txt) 9.3 KB

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