BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3022156 · Received March 26, 2013

    Report

    Report Number
    1525712-2013-02307
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    February 28, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. TERRITORY BUSINESS MANAGER STATED THE DEALER ADVISED THE LEGREST PAD PLATE HARDWARE, THAT'S PERMANENTLY ATTACHED TO THE CALF PAD, STRIPPED CAUSING THE CALF PADS TO FALL OFF THE LEGREST ON BOTH SIDES. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124223 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET MVPS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other