BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOVEROUND CORPORATION

    MDR report key: 1882491 · Received October 20, 2010

    Report

    Report Number
    1056601-2010-00026
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 7, 2010
    Report Date
    October 18, 2010
    Manufacturer
    HOVEROUND CORPORATION
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO MALFUNCTION OF MOTORIZED WHEELCHAIR SUSPECTED. UPON FIELD EVALUATION THE MOTORIZED WHEELCHAIR PERFORMED AS INTENDED. END USER REPORTED TRANSFERRING OUT OF THE MOTORIZED WHEELCHAIR WITH THE FOOTPLATE IN THE UPRIGHT POSITION AND SHE FELL DOWN. THE OWNER'S MANUAL WARNS, "BE SURE TO SECURE FOOTPLATE IN UPRIGHT POSITION AND PLACE BOTH FEET FIRMLY ON GROUND WHEN GETTING INTO OR OUT OF THE SEAT".

    Description of Event or Problem · 1

    END USER ALLEGES WHILE TRANSFERRING OUT OF THE POWER WHEELCHAIR, WITH THE FOOTPLATE IN THE DOWN POSITION, SHE FELL AND ALLEGEDLY REQUIRED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOVEROUND CORPORATION MOTORIZED WHEELCHAIR ITI HOVEROUND CORPORATION MPV5

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization