BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4223355 · Received November 4, 2014

    Report

    Report Number
    9616091-2014-02347
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Report Date
    October 14, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER DEALER, THE END USER IS STATING THAT THE SEAT UPHOLSTERY IS TEARING AWAY FROM THE BOLTS, DEALER QUOTES A NEW SEAT WITH REINFORCEMENT ON THE SEAMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707244 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX T4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other