BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONVEEN COUNTOUR, 800 ML, 65 CM TUBE

    MDR report key: 1910497 · Received November 30, 2010

    Report

    Report Number
    9610694-2010-00020
    Event Type
    Injury
    Date Received
    November 30, 2010
    Report Date
    December 14, 2009
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THREE URINE BAG SAMPLES WERE RECEIVED AND TESTED. TESTING DID NOT PROVIDE AN EXPLANATION AS TO WHAT MAY HAVE CAUSED THE PROBLEM IN THIS REPORT AS LIQUID WAS ABLE TO RUN INTO THE BAGS WITHOUT ANY PROBLEMS. THEREFORE, THE FAILURE COULD NOT BE DUPLICATED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    (B)(4). ACCORDING TO THE INFORMATION RECEIVED, AN END USER REPORTED A BLOCKED INLET ON A URINE BAG. THE URINE WILL NOT FLOW INTO THE BAG. THE ENDUSER SUPPOSES THAT THE WELDING OF THE INLET TUBE AND BAG FOIL IS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVEEN COUNTOUR, 800 ML, 65 CM TUBE URINE BAGE FAQ COLOPLAST A/S 0517701004 2026798

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention