BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3033941 · Received April 3, 2013

    Report

    Report Number
    1525712-2013-02542
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 7, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    FACILITY STATED THAT SEVERAL OF HER SOLARA 3G WHEELCHAIR WHEEL LOCK BRACKETS(LONG SLOTTED FRAME MOUNTED BRACKET) WILL DEFORM AND OPEN OVER TIME WHICH ALLOWS THE BOLTS TO BACK OUT AND THE WHEEL LOCK TO FALL OFF. (B)(4) SPOKE WITH PROVIDER WHO STATED THERE WERE A TOTAL OF 4 SOLARA 3GS WITH THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137476 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other