BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2912211 · Received January 11, 2013

    Report

    Report Number
    1525712-2013-00293
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MDR DECISION DATE: (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. MR. PALMER STATES THAT THE SEAT FRAME THAT BOLTS TO THE MAIN FRAME, AND THE WELDED TAB STICKS OUT AND HAS BROKEN TWICE IN THE SAME SPOT. THIS IS THE SECOND CHAIR HE HAS HAD SINCE 2008 PER THIS ISSUE. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18128 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET CT6A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 Other