BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3200348 · Received July 1, 2013

    Report

    Report Number
    1031452-2013-01249
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES HIS CUSTOMER IS CLOSE OR OVER THE WEIGHT CAPACITY OF THIS CHAIR AND WITH THE CURRENT WHEEL AND CAMBER CONFIGURATION, WHEN THE CUSTOMER IS IN THE CHAIR, THE WHEELS CAMBER MORE IN AND RUB ON THE CLOTHING GUARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299772 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE FLORIDA OPERATIONS CT7A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other