BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3130368 · Received May 24, 2013

    Report

    Report Number
    1525712-2013-04171
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    May 1, 2013
    Manufacturer
    UNKNOWN
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PURCHASED LESS THAN 2 YEARS AGO. LACK OF DURABILITY AND POOR RESPONSE TIME ON GETTING REPLACEMENT PARTS. FOOT RESTS NEEDED REPLACED, REAR FOOT STRAP HAS BOLT MISSING, THE REAR WHEEL ALMOST FELL OFF AND NEEDED WHEEL BEARINGS REPLACED. MOST RECENTLY THE FRONT WHEEL BROKE OFF AND NEEDED WHEEL BEARINGS REPLACED. MOST RECENTLY THE FRONT WHEEL BROKE OFF AND WE WERE STRANDED, THE STAFF AT PVH HAS TRIED TO GET A REPLACEMENT WHEEL FOR WEEKS AND STILL HAVE NO PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232221 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other