BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOVEROUND CORP

    MDR report key: 1911406 · Received November 24, 2010

    Report

    Report Number
    1056601-2010-00027
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 23, 2010
    Manufacturer
    HOVEROUND CORP
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO MALFUNCTION OF MOTORIZED WHEELCHAIR SUSPECTED. END USER REPORTED WHILE OPERATING THE MOTORIZED WHEELCHAIR, WITHOUT THE USE OF A SEAT BELT, SHE FELL OUT OF THE UNIT WHILE DESCENDING A RAMP THAT WAS TOO STEEP AND DID NOT HAVE SAFETY RAILING. THE OWNER'S MANUAL WARNS, 'ALWAYS USE THE SEAT BELT" AND "AVOID RAMPS AND SLOPES THAT ARE TOO STEEP, SUCH AS THOSE THAT EXCEED 5 DEGREES".

    Description of Event or Problem · 1

    END USER ALLEGES WHILE DESCENDING A RAMP IN THE MOTORIZED WHEELCHAIR, SHE FELL OUT OF THE UNIT. END USER WAS NOT WEARING A SEAT BELT. ALLEGEDLY, END USER REQUIRED HOSPITALIZATION DUE TO A FRACTURES LEFT FEMUR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| R