BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONVEEN SECURITY SSU 035

    MDR report key: 2065781 · Received April 21, 2011

    Report

    Report Number
    3003814961-2011-00003
    Event Type
    Injury
    Date Received
    April 21, 2011
    Report Date
    March 25, 2011
    Manufacturer
    COLOPLAST A/S
    Product Code
    EXI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN REQUESTED BUT AS OF TO DATE NO PRODUCT WAS 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 ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN REQUESTED BUT AS OF TO DATE NO PRODUCT WAS 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 ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. FOLLOW UP 1: RETURNED PRODUCT WAS TESTED USING A PEEL ADHESION TEST. THE MEASURED VALUES FOR THE TESTING WERE BELOW THE SPECIFICATION. THEREFORE, THIS COMPLAINT CAN BE CONFIRMED FOR WEAK ADHESIVE BUT NOT THE ORIGINALLY REPORTED "STRONG ADHESIVE".

    Description of Event or Problem · 1

    (B)(6). ACCORDING TO THE INFORMATION RECEIVED, IT WAS REPORTED THAT THE PACKAGING ON THE GREEN BAGS WERE DAMAGED-THEY WERE PERFORATED. ALSO, THE ADHESIVE WAS SO STRONG THAT PART OF THE SKIN OF THE PENIS OF THE END USER CAME OFF WHILE TRYING TO REMOVE THE URISHEATH.

    Description of Event or Problem · 1

    PATIENT IDENTIFIER: (B)(6). DATE OF EVENT: BEST ESTIMATE IS (B)(6) 2011. ACCORDING TO THE INFORMATION RECEIVED, IT WAS REPORTED THAT THE PACKAGING ON THE GREEN BAGS WERE DAMAGED-THEY WERE PERFORATED. ALSO, THE ADHESIVE WAS SO STRONG THAT PART OF THE SKIN OF THE PENIS OF THE END USER CAME OFF WHILE TRYING TO REMOVE THE URISHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVEEN SECURITY SSU 035 MALE EXTERNAL CATHETER UROSHEATH EXI COLOPLAST A/S 0523501017 2617904

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention