BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOVEROUND

    MDR report key: 10106981 · Received June 1, 2020

    Report

    Report Number
    1056601-2020-00010
    Event Type
    Injury
    Date Received
    June 1, 2020
    Date of Event
    April 6, 2020
    Report Date
    June 1, 2020
    Manufacturer
    HOVEROUND CORPORATION
    Product Code
    ITI
    PMA / PMN Number
    K042545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER WAS NOT EXERCISING CAUTION BY OPERATING THE POWER WHEELCHAIR OUTSIDE ON AN UNEVEN SURFACE WITHOUT THE ELEVATING LEG RESTS ATTACHED TO SUPPORT THE END USER'S LEG WHEN THEY HIT A BUMP AND THEIR FOOT HIT THE GROUND. ADDITIONALLY, THE CLIENT WAS NOT WEARING SHOES OR ANY TYPE OF FOOT COVERINGS. HOVEROUND'S OWNER'S MANUAL WARNS "TO REDUCE THE CHANCE OF SERIOUS INJURY OR DEATH FROM TIP-OVER, COLLISION WITH OBSTACLES, LOSS OF CONTROL, OR FALLING FROM THE POWER WHEELCHAIR, KEEP YOURSELF PROPERLY POSITIONED IN THE SEAT: KEEP YOUR BACK AGAINST THE SEAT BACK, ARMS ON THE ARMRESTS, AND YOUR FEET ON THE FOOTPLATE," AND "TO AVOID SERIOUS INJURY OR FATALITY FROM SUDDEN UNEXPECTED MOVEMENT OF THE CHAIR OR CONTACT WITH MOVING PARTS AND OTHER OBJECTS: DO NOT USE YOUR POWER WHEELCHAIR WITH BARE FEET."

    Description of Event or Problem · 1

    THE END USER REPORTED WHILE OPERATING THE POWER WHEELCHAIR OUTSIDE WITHOUT THE ELEVATING LEG RESTS IN PLACE, THE END USER HIT A BUMP AND CUT THEIR TOE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568767 HOVEROUND MOTORIZED WHEELCHAIR ITI HOVEROUND CORPORATION MPV5

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization