BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3840319 · Received May 30, 2014

    Report

    Report Number
    9616091-2014-00965
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    February 27, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE MATRX BACK ON A TRSX5 WHEELCHAIR HAS CRACKED BY THE HEADREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318324 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other