BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4110129 · Received September 23, 2014

    Report

    Report Number
    1525712-2014-06208
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 3, 2014
    Manufacturer
    UNKNOWN
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DEALER THAT THE TIRE MATERIAL FOR A TREX2 WHEELCHAIR WAS CHANGED TO A HARD RUBBER RATHER THAN A SOFT RUBBER MATERIAL CAUSING WHEEL LOCKS NOT TO HOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589445 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR UNKNOWN TREX2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other