BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3033997 · Received April 3, 2013

    Report

    Report Number
    1525712-2013-02559
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 7, 2013
    Manufacturer
    INVACARE
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE CROSSBRACE ON THE WHEELCHAIR BROKE IN HALF. THIS ISSUE COULD CAUSE INSTABILITY FOR THE USER AND THEY COULD FALL OUT OF THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137081 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE PATRIOT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other