BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOVEROUND CORPORATION

    MDR report key: 4884749 · Received July 1, 2015

    Report

    Report Number
    1056601-2015-00034
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    March 25, 2015
    Report Date
    July 1, 2015
    Manufacturer
    HOVEROUND CORPORATION
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MALFUNCTION OF THE DEVICE IS SUSPECTED. END USER WAS NOT EXERCISING CAUTION WHILE DRIVING NEAR THE EDGE OF THE SIDEWALK. HOVEROUND'S OWNER'S MANUAL WARNS END USERS, "TO REDUCE THE CHANCE OF SERIOUS INJURY OR DEATH FROM TIP-OVER, NEVER ATTEMPT TO DRIVE A POWER WHEELCHAIR OFF A CURB HIGHER THAN 1.5 INCHES."

    Description of Event or Problem · 1

    END USER STATES WHILE OPERATING THE POWER WHEELCHAIR ON THE SIDEWALK SHE STOPPED TOO CLOSE TO THE EDGE AND FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428245 HOVEROUND CORPORATION MOTORIZED WHEELCHAIR ITI HOVEROUND CORPORATION HOVEROUND MPV5

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization