BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOVEROUND CORPORATION

    MDR report key: 1831915 · Received September 7, 2010

    Report

    Report Number
    1056601-2010-00017
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    July 6, 2010
    Report Date
    September 3, 2010
    Manufacturer
    HOVEROUND CORP.
    Product Code
    INI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO MALFUNCTION OF MOTORIZED WHEELCHAIR SUSPECTED. END USER REPORTED OPERATING THE MOTORIZED WHEELCHAIR WITH THE FOOTPLATE IN THE UP POSITION WITH HIS FEET DANGLING UNSUPPORTED AND WITHOUT THE USE OF A SEAT BELT. THE OWNER'S MANUAL WARNS, "KEEP YOUR BACK AGAINST THE SEATBACK, ARMS ON THE ARMRESTS, AND YOUR FEET ON THE FOOTPLATE", AND "ALWAYS USE THE SEAT BELT".

    Description of Event or Problem · 1

    END USER ALLEGES WHILE OPERATING THE MOTORIZED WHEELCHAIR IN THE KITCHEN WITH THE FOOTPLATE IN THE UP POSITION AND HIS FEET DANGLING UNSUPPORTED, HE STRUCK A CABINET INJURING HIS TOES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOVEROUND CORPORATION MOTORIZED WHEELCHAIR INI HOVEROUND CORP. TEK XHD

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R