BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVEEN STANDARD BAG FR

    MDR report key: 3140966 · Received June 3, 2013

    Report

    Report Number
    3005945907-2013-00003
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 2, 2013
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    (B)(6). DATE OF EVENT, BEST ESTIMATE (B)(6) 2012. ACCORDING TO THE INFORMATION RECEIVED, THERE WAS A REPORT OF BLOCKED URINE FLOW WITH A URINE BAG DUE TO AIR TRAPPED INSIDE THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244415 CONVEEN STANDARD BAG FR URINE COLLECTION BAG FOR EXTERNAL USE FAQ COLOPLAST A/S 0516701001 3167100

    Patients

    Seq Age Sex Outcome Treatment
    1