BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3232998 · Received July 18, 2013

    Report

    Report Number
    1525712-2013-05860
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 27, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER ALLEGES BECAUSE THERE IS NO PADDING IN THE GAP BETWEEN HIS ARMRESTS AND THE FRAME OF THE CHAIR HE TENDS TO STRATCH HIS HANDS WHEN USING MANEUVERING IN THE CHAIR. CONSUMER ALSO ALLEGES THAT WHEN HE IS ON THE BUS, THE RATTLE MAKES THE SPEED CHANGE ON HIS CHAIR, SO WHEN HE GOES TO GET OFF OF THE CHAIR, IT GOES FASTER THAN HE INITIALLY SET IT ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332977 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other