BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOVEROUND CORPORATION

    MDR report key: 1935320 · Received December 16, 2010

    Report

    Report Number
    1056601-2010-00031
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    September 1, 2010
    Report Date
    December 15, 2010
    Manufacturer
    HOVEROUND CORP.
    Product Code
    INI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MALFUNCTION OF MOTORIZED WHEELCHAIR SUSPECTED. END USER REPORTED THAT SHE FELL DOWN AFTER STANDING ON THE POWER WHEELCHAIR'S FOOTPLATE. THE OWNER'S MANUAL WARNS, "DO NOT STAND ON THE FOOTPLATE."

    Description of Event or Problem · 1

    THE END USER ALLEGES WHILE STANDING ON THE MOTORIZED WHEELCHAIR'S FRONT FOOTPLATE SHE FELL DOWN AND INJURED HER RIGHT LEG. 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 INI HOVEROUND CORP. MPV5

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization