The Medical Device Reporting dataset contains information from CDRH’s device experience reports on devices which may have malfunctioned or caused a death or serious injury.
The dataset contains 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.
The FDA is required under the Freedom of Information and Privacy Acts (SEC 552, Title 5, USC) (PL 93-579) to delete, prior to public disclosure, any information that constitutes trade secrets, and confidential, commercial, or financial information; and any personal, medical and similar information that would constitute a clearly unwarranted invasion of personal privacy. Included in the deletion requirements are all identification of the reporters of the events.