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MAUDE - Manufacturer and User Facility Device Experience

  • Please note:  due to technical difficulties all fields may not currently be available, if you are interested in receiving an available adverse event report please contact our Freedom of Information Office with any requests."
  • 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.
  • The on-line search allows you to search CDRH database information on medical devices which may have malfunctioned or caused a death or serious injury. MAUDE is scheduled to be updated monthly 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.
Search MAUDE Database
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Product Code
 (mm/dd/yyyy)  use calendar to select date  use calendar to select date
Enter one or a combination of the MAUDE Search Values and select Search
For full-text search, select Go To Simple Search button
         
Medical Device Reporting Search: (for incidents before July 31, 1996)
 
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