How can I find out if any problems with medical devices have been reported?

Answer

FDA maintains information collected from device experience reports on medical devices that may have malfunctioned or caused a death or serious injury. This data is contained in the:

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• Medical Device Reporting (MDR) database - The MDR files contain reports received under both the mandatory Medical Device Reporting Program from 1984 - 1996, and the voluntary reports up to June 1993. The database currently contains over 600,000 reports.
  
• Manufacturer and User Facility Device Experience (MAUDE) database - The MAUDE data consists of all voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. The database currently contains about 1.2 million reports.

MAUDE on-line search http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm

Last Reviewed: 04/23/2008