Medical Device Reports (MAUDE)

$300.00

Source U.S. Food and Drug Administration
File Size 5 GB
Dates Covered 1991 – June 2013 (contact NICAR for archived data to 1984)
Cost Snapshot

  • Nonmembers $300
  • Members $100
Categories: ,

Description

The MAUDE dataset includes information about problems that occurred with medical devices, including injuries, deaths and/or product malfunctions.The data comes 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.

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

The files are in CSV format. If you plan to use Microsoft Access to analyze the data, you must link to, rather than import, the tables.

Record layouts and samples of this database

Data sample (maudesample.xls) 116.8 KB
Schema (maude.pdf) 298.7 KB
Main documentation (maude_readme.txt) 16.0 KB
Record layout (MAUDElay.txt) 9.3 KB

Related Tipsheets

Related Stories

  • Foreign Objects
    A Star-Ledger investigation revealed that “while implants save or improve the lives of millions of people, thousands suffer in pain, disfigurement, immobility and, in some cases, death. The multimillion-dollar medical implant industry is supposed to be overseen by the Food and Drug Administration, but in fact it is regulated so laxly that devices often reach the market without clinical testing and with little oversight afterwards.”
  • Drug Pump’s Deadly Trail
    “This project questions the standard conclusion that a great deal of blame falls on nursing errors – especially medication errors. In many cases, it’s not the people. It’s the machine. The Tallahassee Democrat shows that one of the most common hospital bedside devices – the drug pump – is so prone to human error that it invites mistake. What’s worse, when misprogrammed, the pump defaults to a setting that, when used with morphine, is instantly lethal.”