BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4131681 · Received October 1, 2014

    Report

    Report Number
    1056571-2014-00047
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 15, 2014
    Manufacturer
    INVACARE TOP END
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE END-USER THAT THE LEFT HEAD TUBE IS STRIPPED AND THE FORK WILL NO LONGER STAY ATTACHED TO THE CHAIR. NO PATIENT INJJURY REPORTED, NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612609 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TOP END CT7A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other