BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3090808 · Received May 2, 2013

    Report

    Report Number
    1525712-2013-03473
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Report Date
    April 8, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DID NOT ACT UP FOR THE DEALER. DEALER SAYS, THE USER SAYS THE CHAIR WENT OUT OF CONTROL AND HIT A WALL. SHE SAYS SHE HIT HER KNEES AND HEAD, AND DID NOT SEEK MEDICAL ATTENTION. THIS HAPPENED ONCE. SHE SAYS THAT SHE DID NOT GET ANY CODE AND DROVE AWAY WITHOUT HAVING TO TURN CHAIR OFF AND BACK ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192309 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 3GAR-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other