BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONVEEN SECURITY URINE BAG, 500 ML, 50 CM TUBE

    MDR report key: 1910662 · Received November 30, 2010

    Report

    Report Number
    3005945907-2010-00034
    Event Type
    Injury
    Date Received
    November 30, 2010
    Report Date
    August 26, 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

    THE PRODUCT WAS NOT AVAILABLE TO BE RETURNED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    (B)(4). ACCORDING TO THE INFORMATION RECEIVED, URINE FLOWS INTO THE BAG, BUT AGAIN BACKWARDS. THE END USER IS WELL TRAINED WITH THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVEEN SECURITY URINE BAG, 500 ML, 50 CM TUBE URINE COLLECTION BAG FOR EXTERNAL USE FAQ COLOPLAST A/S 0516101004 1988716

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention