BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4131173 · Received October 1, 2014

    Report

    Report Number
    9616091-2014-02041
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 11, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PROVIDER THAT THE RIGHT SIDE SEAT FRAME IS BENT INWARD AND DOWNWARD TOWARDS THE MIDDLE OF THE CHAIR. PAINT IS CHIPPED WHERE THE CROSSBAR MEETS THE SEAT FRAME ON RIGHT SIDE. THE PROVIDER STATES THE DEVICE WAS IN THIS CONDITION WHEN REMOVED FROM THE SHIPPING CARTON, AND IS AN OUT-OF-BOX ISSUE. NO PATIENT INJURY REPORTED, NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612678 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other