BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOVEROUND CORPORATION

    MDR report key: 2190441 · Received July 28, 2011

    Report

    Report Number
    1056601-2011-00014
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 6, 2011
    Report Date
    July 27, 2011
    Manufacturer
    HOVEROUND CORP.
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS NOT HAD ACCESS TO THE MOTORIZED WHEELCHAIR TO EVALUATE, HOWEVER, NO MALFUNCTION OF MOTORIZED WHEELCHAIR SUSPECTED. ACCORDING TO THE POLICE REPORT THE END USER WAS IN VIOLATION OF A LOCAL PEDESTRIAN CODE BY CROSSING THE STREET IN THE MOTORIZED WHEELCHAIR WITHOUT USING A CROSSWALK. THE OWNER'S MANUAL WARNS, "TO AVOID SERIOUS INJURY OR DEATH FROM BEING STRUCK BY A MOTOR VEHICLE, WHEN DRIVING YOUR POWER WHEELCHAIR NEAR TRAFFIC: OBEY ALL LOCAL PEDESTRIAN TRAFFIC RULES."

    Description of Event or Problem · 1

    ACCORDING THE POLICE REPORT, THE END USER WAS OPERATING THE MOTORIZED WHEELCHAIR IN THE ROADWAY IN VIOLATION OF A LOCAL PEDESTRIAN CODE. ALLEGEDLY, AS A RESULT OF THE INCIDENT THE END USER REQUIRED HOSPITALIZATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization