BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3913625 · Received July 3, 2014

    Report

    Report Number
    1531186-2014-02385
    Date Received
    July 3, 2014
    Report Date
    June 2, 2014
    Manufacturer
    KENTSTONE
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PER PROVIDER, THE SUPPORT BEAM BROKE FROM UNDER SEAT CUSHION ON THE 65960 KNEE WALKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391788 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ KENTSTONE 65960

    Patients

    Seq Age Sex Outcome Treatment
    1 Other