BEUDAMED
    FDA Adverse Event Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3971442 · Received July 31, 2014

    Report

    Report Number
    3008262382-2014-00440
    Date Received
    July 31, 2014
    Report Date
    June 27, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END-USER ADVISED RIDING DOWN THE HILL TO GET MAIL AND CHAIR STOPPED. END-USER RESTARTED CHAIR AND THEN WENT SLOW AND THEN IT TOOK OFF AND THEN STOPPED ALL OF SUDDEN AND END-USER SLIPPED OUT OF THE CHAIR AND FELL ON THE GROUND. END-USER ADVISED LEGS WERE SCRAPED UP AND ARMS BRUISED. END-USER ADVISED WENT TO THE HOSPITAL. END-USER ADVISED THIS HAPPENED OVER A YEAR AGO, END-USER COULD NOT PROVIDE ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447360 POWERED WHEELCHAIR 890.3860 ITI INVACARE REHABILITATION EQUIP M51PSEMIRED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other