BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4243675 · Received November 11, 2014

    Report

    Report Number
    1056571-2014-00056
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 23, 2014
    Manufacturer
    INVACARE TOP END
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER ALLEGES THE SEAT RAIL IS CRACKED IN TWO PLACES ON A CT7A WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726693 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TOP END CT7A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other