BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2923612 · Received January 22, 2013

    Report

    Report Number
    1525712-2013-00527
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    January 19, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6)SEH. NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER DEALER ARM PADS ARE CRACKED AND SHARP. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29562 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET SPT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other