MAUDE with Patient Involvement

$79 / year

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.

Complexity

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.

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

John Snow Labs Standard License

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

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
MDR_Report_KeyPatient_Sequence_NumberDate_ReceivedSequence_Number_TreatmentSequence_Number_Outcome
621691212017-01-018
621691312017-01-018
621691312017-01-018
621691312017-01-018
621691312017-01-018
621691312017-01-018
621691312017-01-018
621691312017-01-018
621691312017-01-018
621691312017-01-018