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Problems with Medical Devices

What Problems Have Been Reported?

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

  • Medical Device Reporting (MDR) database - The MDR files contain reports received under both the mandatory Medical Device Reporting Program (MDR) 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.

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.
MDR on-line search
MAUDE on-line search

The data is also available in zipped files for downloading.
MDR files
MAUDE files

Updated 07/20/2007

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