BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3243511 · Received July 23, 2013

    Report

    Report Number
    9616091-2013-01290
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    July 2, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TREX2 MANUAL WHEELCHAIR HAD A SEAT UPHOLSTERY WITH HOLES AND WAS SAGGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342294 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TREX2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other