BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOVEROUND CORPORATION

    MDR report key: 3221198 · Received July 1, 2013

    Report

    Report Number
    1056601-2013-00015
    Event Type
    Death
    Date Received
    July 1, 2013
    Date of Event
    August 23, 2012
    Report Date
    June 28, 2013
    Manufacturer
    HOVEROUND CORP.
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POWER WHEELCHAIR IS NOT AVAILABLE FOR EVAL BY HOVEROUND; HOWEVER, NO MALFUNCTION OF THE POWER WHEELCHAIR SUSPECTED AS THE END USER WAS STRUCK BY A MOTOR VEHICLE WHILE CROSSING THE STREET. HOVEROUND'S OWNER'S MANUAL WARNS "TO AVOID SERIOUS INJURY OR DEATH FROM BEING STRUCK BY A MOTOR VEHICLE, WHEN DRIVING YOUR POWER WHEELCHAIR NEAR TRAFFIC CROSS ROAD AT LOCATIONS WHERE YOU ARE MOST VISIBLE TO MOTOR TRAFFIC."

    Description of Event or Problem · 1

    LAW ENFORCEMENT ADVISED THAT END USER WAS STRUCK BY A MOTOR VEHICLE WHILE CROSSING A STREET IN THE POWER WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297366 HOVEROUND CORPORATION MOTORIZED WHEELCHAIR ITI HOVEROUND CORP. HOVEROUND MPV5

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death