BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE STEERABLE ALUMINIUM KNEE WALKER

    MDR report key: 7717937 · Received July 24, 2018

    Report

    Report Number
    MW5078586
    Event Type
    Malfunction
    Date Received
    July 24, 2018
    Date of Event
    July 17, 2018
    Report Date
    July 19, 2018
    Manufacturer
    MEDICAL DEPOT INC. / DRIVE DEVILBISS HEALTHCARE
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PURCHASED A DRIVE KNEE-SCOOTER (MOBILITY DEVICE/MEDICAL DEVICE) FROM THAT COMPANY; TILLER SCREW, WHICH CONTROLS STEERING OF THE DEVICE, WILL NOT HOLD NO MATTER HOW LIGHTLY SECURED IT IS. HANDLES GO ONE WAY, FRONT WHEELS GO THE OTHER WAY, MAKING STEERING THE DEVICE IMPOSSIBLE AND USE OF THE DEVICE BY A DISABLED PERSON (SUCH AS MYSELF) IS RENDERED QUITE UNSAFE. THIS MEDICAL DEVICE IS DEFECTIVE AND UNSAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559258 DRIVE STEERABLE ALUMINIUM KNEE WALKER WALKER MECHANICAL ITJ MEDICAL DEPOT INC. / DRIVE DEVILBISS HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR