BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOVEROUND CORPORATION

    MDR report key: 3231701 · Received July 11, 2013

    Report

    Report Number
    1056601-2013-00018
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 10, 2013
    Report Date
    July 11, 2013
    Manufacturer
    HOVEROUND CORP.
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OPERATOR ERROR: NO MALFUNCTION SUSPECTED AS END USER RELEASED THE JOYSTICK QUICKLY WHILE DRIVING DOWN A NON-ADA COMPLAINT RAMP WITHOUT WEARING SEAT BELT. HOVEROUND OWNER'S MANUAL WARNS END USERS "TO AVOID SERIOUS INJURY OR DEATH ALWAYS WEAR SEAT BELT", AND "AVOID RAMPS AND SLOPES THAT ARE TOO STEEP SUCH AS THOSE THAT EXCEED 5 DEGREES SLOPE," AND "SUDDEN CHANGE IN MOTION, LOSS OF CONTROL, OR TIP OVER MAY CAUSE A COLLISION OR FALL FROM SEAT."

    Description of Event or Problem · 1

    END USER'S DAUGHTER REPORTS END USER WAS DRIVING THE POWER WHEELCHAIR DOWN A RAMP AND RELEASED THE JOYSTICK QUICKLY. HE WAS NOT WEARING THE SEATBELT AND FELL OUT OF THE POWER WHEELCHAIR INJURING HIS LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320023 HOVEROUND CORPORATION MOTORIZED WHEELCHAIR ITI HOVEROUND CORP. HOVEROUND MPV5

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization