Others titles

  • Medical Devices Adverse Events
  • FDA MAUDE Dataset

Keywords

  • MAUDE Devices
  • User Facility Devices
  • MAUDE Database
  • MAUDE Distributor Reports
  • Manufacturer Reports

MAUDE with Patient Involvement

MAUDE (Manufacturer and User Facility Device Experience) dataset represents reports of adverse events involving medical devices the data consist of voluntary Reports since June 1993, User facility Reports since 1991, Distributor Reports since 1993, and Manufacturer Reports since August 1996.

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Description

Manufacturer and User Facility Device Experience Database represents Reports of adverse Events involving medical Devices.
The dataset contains 6 fields including an MDR Report key, the Report Number and the Date of the Event. The incidents are collected in a publicly available FDA database called MAUDE – short for Manufacturer and User Facility Device Experience. As part of the openFDA project, there is now an Application Programming Interface (API) for this dataset, which provides a way for software to interact directly with the data. This API will allow developers and researchers to easily query thousands of reports dating back to the early 1990s.

About this Dataset

Data Info

Date Created

2017-02-08

Last Modified

2017-04-26

Version

2017-04-26

Update Frequency

Irregular

Temporal Coverage

N/A

Spatial Coverage

United States

Source

John Snow Labs; U.S. Food and Drug Administration (FDA);

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

MAUDE Devices, User Facility Devices, MAUDE Database, MAUDE Distributor Reports, Manufacturer Reports

Other Titles

Medical Devices Adverse Events, FDA MAUDE Dataset

Data Fields

Name Description Type Constraints
MDR_Report_KeyMDR Report Keystringrequired : 1
Patient_Sequence_NumberPatient Sequence Numberstring-
Date_ReceivedReceived Datedate-
Sequence_Number_TreatmentTreatment Numberstring-
Sequence_Number_OutcomeOutcome of Treatmentintegerlevel : Ratio

Data Preview

MDR Report KeyPatient Sequence NumberDate ReceivedSequence Number TreatmentSequence Number Outcome
621691212017-01-018
621691312017-01-018
621691412017-01-018
621691512017-01-018
621691612017-01-018
621691712017-01-018
621691812017-01-018
621691912017-01-018
621692012017-01-018
621692112017-01-018