BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3092906 · Received May 3, 2013

    Report

    Report Number
    1525712-2013-03511
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 9, 2013
    Manufacturer
    UNKNOWN
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH THE ARM ON AN UNKNOWN MANUAL WHEELCHAIR NOT BEING ALIGNED PROPERLY. THIS MAY COMPROMISE THE STABILITY OF THE SIDE FRAME AND THE USER IF THE ARM IS USED FOR SUPPORT GETTING INTO OR OUT OF THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194570 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other