BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOVEROUND CORPORATION

    MDR report key: 4071279 · Received September 5, 2014

    Report

    Report Number
    1056601-2014-00014
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    January 27, 2013
    Report Date
    August 27, 2014
    Manufacturer
    HOVEROUND CORPORATION
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    HOVEROUND HAS NOT BEEN GIVEN ACCESS TO THE POWER WHEELCHAIR TO EVALUATE EQUIPMENT; HOWEVER, NO MALFUNCTION OF THE POWER WHEELCHAIR SUSPECTED AS THE SEAT BACK IS INTENDED TO FOLD DOWN. HOVEROUND'S OWNER'S MANUAL CAUTIONS END USERS "THE SEAT BACK WILL FOLD FORWARD WHEN PUSHED FROM THE REAR OR PULLED FROM THE FRONT."

    Additional Manufacturer Narrative · 1

    INCIDENT DATE CORRECTED.

    Description of Event or Problem · 1

    END USER ALLEGEDLY FELL WHEN ATTEMPTING TO TRANSFER FROM HER BED INTO THE POWER WHEELCHAIR BY LEANING ON THE SEAT BACK.

    Description of Event or Problem · 1

    END USER ALLEGEDLY FELL WHEN ATTEMPTING TO TRANSFER FROM HER BED INTO THE POWER WHEELCHAIR BY LEANING ON THE SEAT BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543570 HOVEROUND CORPORATION MOTORIZED WHEELCHAIR ITI HOVEROUND CORPORATION HOVEROUND MPV5

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization