BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOVEROUND CORPORATION

    MDR report key: 1233887 · Received November 13, 2008

    Report

    Report Number
    1056601-2008-00028
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    August 11, 2008
    Report Date
    November 10, 2008
    Manufacturer
    HOVEROUND CORP.
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER'S SPOUSE DECLINED SERVICE/REPAIR TO THE MOTORIZED WHEELCHAIR AND HAS INFORMED HOVEROUND THAT THE END USER HAS DISCONTINUED USE OF THE MPV4 MOTORIZED WHEELCHAIR. DUE TO DECLINED SERVICE/REPAIR, PARTS WERE UNAVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    THE END USER ALLEGES WHILE DESCENDING A NON-ADA COMPLIANT RAMP IN THE MOTORIZED WHEELCHAIR, THE UNIT STOPPED AND SHE FELL OUT OF THE SEAT. ALLEGEDLY, AS A RESULT, THE END USER FRACTURED HER RIGHT SHOULDER AND REQUIRED HOSPITALIZATION. END USER ADVISED SHE WAS NOT WEARING A SEAT BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOVEROUND CORPORATION MOTORIZED WHEELCHAIR ITI HOVEROUND CORP. MPV4

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R