BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3822095 · Received May 20, 2014

    Report

    Report Number
    1525712-2014-02548
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    UNKNOWN
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    TREX2 STANDARD WHEEL CHAIR HAS A BROKEN WELD WHERE THE WHEEL AXLE MOUNTS ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299497 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR UNKNOWN TREX2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other