BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMEX

    MDR report key: 4934884 · Received June 29, 2015

    Report

    Report Number
    4934884
    Event Type
    Malfunction
    Date Received
    June 29, 2015
    Date of Event
    June 23, 2015
    Report Date
    June 29, 2015
    Manufacturer
    GF HEALTH PRODUCTS, INC
    Product Code
    INB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT PUT HER WEIGHT ON THE ARMS OF ONE OF OUR PORTABLE DROP ARM COMMODES AND ONE OF THE DROP ARMS GAVE WAY. SHE FELL TO THE FLOOR HIT HER MOUTH AND DAMAGED SOME OF HER TEETH. AFTER THE INCIDENT IT WAS NOTICED THAT THE DROP ARM THAT GAVE WAY WOBBLED ABOUT 1/2 AN INCH COMPARED TO A NEW COMMODE THAT DID NOT WOBBLE AT ALL. IT WAS ALSO NOTICED OF THE COMMODE INVOLVED IN THE INCIDENT THAT THE DROP ARM LOCKING MECHANISM WOULD RELEASE WHEN PRESSURE WAS PUT ON THE VERTICAL SIDE OF THE DROP ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420519 LUMEX COMMODE INB GF HEALTH PRODUCTS, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *