FDA Medical Device Incident Reports

• by djohnston
• 2016-05-22 09:05:12
• General Posting
• 1019 views
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FDA online search:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=803.19

Please report any and all incidents that you experience to the FDA - you may save someone's life.

Manufacturer and User Facility Device Experience Database - (MAUDE)

MAUDE data represents reports of adverse events involving medical devices. The download data files consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. The searchable database data contains the last 10 year's data. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19.

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. MAUDE data is current through the end of the previous month. 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 data is also available in zipped files for downloading. The data is updated on a weekly 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.