BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUELLER WRIST BRACE

    MDR report key: 7401249 · Received April 5, 2018

    Report

    Report Number
    2110420-2017-00001
    Event Type
    Injury
    Date Received
    April 5, 2018
    Date of Event
    January 4, 2018
    Report Date
    February 1, 2018
    Manufacturer
    2110420
    Product Code
    IQI
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER CLAIMS BRACE HAS BEEN PROBLEMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244195 MUELLER WRIST BRACE MUELLER WRIST BRACE IQI 2110420 222 000

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention