BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4126357 · Received September 29, 2014

    Report

    Report Number
    1525712-2014-06463
    Event Type
    Malfunction
    Date Received
    September 29, 2014
    Report Date
    September 16, 2014
    Manufacturer
    UNKNOWN
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER STATED THAT THE CAMBER TUBE O HIS CT7A WHEELCHAIR SLIDES OFF THE AXLE ON BOTH SIDES. STATES HE WAS IN THE CHAIR WHEN THE CAMBER TUBE CAME OFF, THE WHEEL CAME OFF, AND HE SUSTAINED A SEVERE ROAD RASH. THE PROBLEM WITH THE CAMBER HAS CAUSED ABNORMAL WEAR ON ALL FOUR WHEELS AND IS CAUSING THEM TO WOBBLE. NO ALLEGED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606547 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR UNKNOWN CT7A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other