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.
The Freedom of Information Act (FOIA) is found in Title 5 of the United States Code, Section 552. FOIA generally provides that any person has the right to request access to federal agency records or information except to the extent the records are protected from disclosure by any of nine exemptions contained in the law or by one of three special law enforcement record exclusions. FOIA also applies to the release of information in the reports found in MAUDE. Of the nine exemption categories that authorize government agencies to withhold information, only two of these nine are used for reports found in MAUDE: Exemption 4, trade secrets and confidential business information; and exemption 6, personnel and medical files. Starting February 1, 2010 the redacted text of the event description and manufacturer narrative may contain references to the above exemptions where such information has been removed. For example, "(b) (4)" may be found in place of the product's composition and "(b) (6)" may be found in place of a patient's age.