BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOVEROUND CORPORATION

    MDR report key: 1790150 · Received August 3, 2010

    Report

    Report Number
    1056601-2010-00015
    Event Type
    Injury
    Date Received
    August 3, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 2, 2010
    Manufacturer
    HOVEROUND CORPORATION
    Product Code
    INI
    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 WITH A LOOSE OBJECT HANGING FROM THE JOYSTICK AND WITHOUT THE USE OF A SEAT BELT, THE UNIT STRUCK A WALL AND INJURED HER TOES. THE OWNER'S MANUAL WARNS, "DO NOT WEAR LOOSE CLOTHING OR JEWELRY". FOR EXAMPLE, A LOOSE BATHROBE SLEEVE OR BRACELET CAN ACCIDENTALLY GET CAUGHT IN WHEELS OR CATCH AND MOVE THE JOYSTICK CAUSING THE POWER WHEELCHAIR TO MOVE UNEXPECTEDLY", AND, "ALWAYS USE THE SEAT BELT".

    Description of Event or Problem · 1

    END USER ALLEGES WHILE OPERATING THE MOTORIZED WHEELCHAIR WITH A LOOSE OBJECT HANGING FROM THE JOYSTICK AND WITHOUT THE USE OF A SEAT BELT, THE UNIT STRUCK A WALL. ALLEGEDLY, AS A RESULT OF THE INCIDENT THE END USER INJURED HER TOES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention