BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2960038 · Received February 13, 2013

    Report

    Report Number
    1525712-2013-01123
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES ON THAT A FEW PIECES OF THE BACK CANE MOUNTING HARDWARE HAD WORKED THEMSELVES LOOSE AND ARE NOW LOST. INDIVIDUAL PIECES NOT AVAILABLE BY THEMSELVES, DEALER ALSO STATES THAT THE BACK CANES ARE STRIPPED WHERE THE HARDWARE GOES. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63146 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other