BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 4223251 · Received November 4, 2014

    Report

    Report Number
    9616091-2014-02358
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Report Date
    October 14, 2014
    Manufacturer
    INVAMEX
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    STATES THAT THERE IS SOMETHING THAT IS BENT THAT WILL NOT ALLOW THE SEAT OR THE LID TO SNAP ON PROPERLY ON A 9650-4 COMMODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705248 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX INVAMEX 9650-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other