BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOVERROUND CORPORATION

    MDR report key: 2896274 · Received December 31, 2012

    Report

    Report Number
    1056601-2012-00043
    Event Type
    Injury
    Date Received
    December 31, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 28, 2012
    Manufacturer
    HOVEROUND CORP.
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO MALFUNCTION OF MOTORIZED WHEELCHAIR SUSPECTED. UPON FIELD EVAL THE RAMP THE END USER REPORTED USING WHILE OPERATING THE MOTORIZED WHEELCHAIR WAS NOT WITHIN ADA GUIDELINES. THE OWNER'S MANUAL WARNS, "AVOID RAMPS AND SLOPES THAT ARE TOO STEEP, SUCH AS THOSE THAT EXCEED 5 DEGREES. FOR EXAMPLE, A 12-INCH RULER WITH ONE END RAISED 1 INCH WILL HAVE A 5 DEGREE SLOPE, AND "INFO ABOUT THE DESIGN OF RAMPS APPROPRIATE FOR WHEELCHAIR ACCESS FOR YOUR HOME ARE CONTAINED IN GUIDANCE FROM THE AMERICANS WITH DISABILITIES ACT, WHICH CAN BE LOCATED (B)(4)".

    Description of Event or Problem · 1

    END USER ALLEGES WHILE OPERATING THE MOTORIZED WHEELCHAIR DOWN A RAMP THE UNIT FELL FORWARD. THE END USER WAS NOT WEARING A SEAT BELT. ALLEGEDLY, AS A RESULT OF THE INCIDENT THE END USER WAS HOSPITALIZED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization