BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3071995 · Received April 22, 2013

    Report

    Report Number
    9616091-2013-00680
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 28, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH THE BROKEN CROSS BRACE ON A 9XT MANUAL WHEELCHAIR. THIS EVENT COULD CAUSE POSSIBLE PRODUCT INSTABILITY AND THE POTENTIAL FOR NOT PERMITTING THE CHAIR TO MAINTAIN ITS INTENDED WEIGHT-BEARING STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171323 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9XT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other