BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4240781 · Received November 10, 2014

    Report

    Report Number
    9616091-2014-02418
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 22, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER STATED THE FRONT ARM SOCKET IS "WOLLED" OUT, ARM WILL NOT STAY TIGHT. THE DEALER STATED IT IS WOBBLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721661 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9XT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other