The files provided below contain information from CDRH's device experience reports on devices which may have malfunctioned or caused a death or serious injury. The 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.
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 during the years 1984 through 1996.
Please note that 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.
The following files contain DEN data broken out by year they were received. Each file is large, and complete for that year. As such, these are compressed data files using the zip format. Once downloaded , these files should be unzipped and viewed with a word processor or database software. We do not currently provide a search mechanism for these files, but are working on developing a mechanism for on-line searches.
The MDR data has one record per line, with the data fields in the following pipe-delimited, (i.e., "|") format:
Access Type and Number|Date Received|Product Description|Manufacturer name code|Manufacturer Name|Street address|City|State
|Zipcode|Report type|Model number|Catalog number| FDA panel code|FDA Product code|Event description type|Event description|Closeout text
Following are the compressed MDR data files listed with their compressed and uncompressed file sizes. The last file listed, disclaim.zip, contains a disclaimer from the manufacturer for each report. This disclaimer absolves them from any liability concerning the report and is necessary for Freedom of Information purposes.
|File name||Compressed Size||Uncompressed Size|
The following list contains other known sources of DEN information, available for a fee. These data may be available in a number of formats, including tape media and hard copy, and are also redacted under the Freedom of Information and Privacy Acts.
National Technical Information Service (NTIS)
Springfield, VA 22161;
Emergency Care Research Institute (ECRI)
5200 Butler Pike, Plymouth Meeting, PA 19462;
MDR Watch, Washington Business Information, Inc.,
1117 N. 19th Street, Arlington, VA 22209;
Medical Device Approval Letter/GMP Design Controls Review
6506 Old Stage Road, Suite 100
Rockville, MD 20852;
phone: 8007-776-510K, FAX: 301-468-0475