BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOVEROUND CORPORATION

    MDR report key: 1070913 · Received July 3, 2008

    Report

    Report Number
    1056601-2008-00015
    Event Type
    Injury
    Date Received
    July 3, 2008
    Date of Event
    March 5, 2008
    Report Date
    June 5, 2008
    Manufacturer
    HOVEROUND CORP.
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO MALFUNCTION OF MOTORIZED WHEELCHAIR SUSPECTED. THE END USER REPORTED OPERATING THE EQUIPMENT IN THE RAIN AND WITHOUT THE USE OF A SEAT BELT. THE TEK XHD OWNER'S MANUAL WARNS, "DO NOT SUBJECT THE POWER WHEELCHAIR TO DIRECT RAIN, WATER, SLUSH OR SNOW," AND "ALWAYS USE THE SEAT BELT".

    Description of Event or Problem · 1

    END USER ALLEGES WHILE OPERATING THE MOTORIZED WHEELCHAIR, IN THE RAIN AND WITHOUT THE USE OF A SEAT BELT, THE UNIT STOPPED AND SHE FELL OUT OF THE SEAT. ALLEGEDLY, AS A RESULT OF THE INCIDENT, THE END USER SUSTAINED MULTIPLE FRACTURES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention