BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINARY LEG BAG

    MDR report key: 6141010 · Received November 30, 2016

    Report

    Report Number
    MW5066471
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    November 13, 2016
    Report Date
    November 16, 2016
    Manufacturer
    HOLLISTER
    Product Code
    NNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LEG BAG LEAKS URINE FROM INTERFACE WHERE DRAINAGE VALVE IS INSERTED TO THE BAG. I DESTROYED BAG 1 AND REPLACED WITH BAG 2. BAG 2 HAS THE SAME PROBLEM. I ONLY USED A TOTAL OF 3 BAGS. BAG OK; BAG 2 DEFECTIVE. BAG 3 DEFECTIVE. TWO THIRDS IS POOR QUALITY TO ME!

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788064 URINARY LEG BAG URINARY LEG BAG NNW HOLLISTER
    788065 URINARY LEG BAG URINARY LEG BAG NNW HOLLISTER 6EO3C

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR