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MDR Data Files

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
mdr84.zip 24KB 78KB
mdr85.zip 1.7MB 10MB
mdr86.zip 2.2MB 13MB
mdr87.zip 2.0MB 12MB
mdr88.zip 1.9MB 11MB
mdr89.zip 2.2MB 14MB
mdr90.zip 3.2MB 18MB
mdr91.zip 5.0MB 30MB
mdr92.zip 7.3MB 49MB
mdr93.zip 8.5MB 56MB
mdr94.zip 8.5MB 63MB
mdr95.zip 8.6MB 47MB
mdr96.zip 8.5MB 42MB
mdr97.zip 11.0KB 45KB
disclaim.zip 163KB 2MB

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;
phone: 703-487-4630

Emergency Care Research Institute (ECRI)
5200 Butler Pike, Plymouth Meeting, PA 19462;
phone: 610-825-6000

MDR Watch, Washington Business Information, Inc.,
1117 N. 19th Street, Arlington, VA 22209;
phone: 703-247-3434

phone: 301-975-0110

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

Updated July 28, 1998

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