Updated FDA Medical Device Reports (MAUDE) available in the data library

The NICAR Database Library has just updated the U.S. Food and Drug Administration’s Manufacturer and User Facility Device Experience Database(MAUDE).

WHAT’S IN IT?
Current with reports received by the FDA through June 28, 2013, the data include nearly 3 million records of problems involving medical devices. These problems include injuries, deaths and product malfunctions. 

The dataset has a unique MDR report number for each incident and contact detail for the manufacturers and distributors. The age and expiration date for devices are also available in some instances. A memo field includes narratives that describe how problems occurred. 

The reports are pulled from two forms: Medwatch 3500 and 3500A. Health officials use form 3500 to voluntarily report adverse events. User facilities (hospitals, clinics, etc.) as well as product distributors and manufacturers are required to report problems; they use Medwatch 3500A.

WHAT FORMAT?
MAUDE files come in CSV format and SQL format (for MySQL users only). If you'd like something different, contact us and we'll do our best to help you out. Email datalib@ire.org or call (573) 884-7711.

WHAT CAN I DO WITH IT?
The reports in this database detail problems with medical devices, both malfunctions and in some cases human error. Journalists can research reports on a particular brand device to identify, for example, if it is prone to cause complications. Keep in mind that some of these reports are voluntary, and that some devices are used much more heavily than others.  

Also note that the data do not include patient-specific information (which has been removed for privacy reasons) or geographic information. 

Peruse IRE tipsheets on all things health-related here: https://www.ire.org/resource-center/tipsheets/

Here are several that may help:

• Health Reporting Technologies
• Health Care Survival Guide: Investigating America's Hospitals
• Investigating Healthcare

Search IRE's cache of over 20,000 investigative stories here: https://www.ire.org/resource-center/stories/

To order the full MAUDE database online, visit the online store at https://www.ire.org/nicar/database-library/databases/medical-device-reports-maude/ or contact the library.

datalib@ire.org
(573) 884-7711

Call or email with questions.

Liz Lucas, Director

Students:
Travis Hartman
Qing Tian
James Gordon

NICAR is a joint program of IRE and the Missouri School of Journalism.