BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBOUND AIR WALKER MD

    MDR report key: 7455123 · Received April 24, 2018

    Report

    Report Number
    2085446-2018-00001
    Event Type
    Injury
    Date Received
    April 24, 2018
    Report Date
    April 24, 2018
    Manufacturer
    OSSUR AMERICAS, INC.
    Product Code
    ITW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CLAIM OF PRESSURE AND SWELLING ON TENDONS WHILE WEARING ORTHOPEDIC WALKING BOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296848 REBOUND AIR WALKER MD JOINT, ANKLE, EXTERNAL BRACE ITW OSSUR AMERICAS, INC. B-242900003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other