BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S2S/SUR-FIT NATURA 2 PC - 2 PC UROSTOMY POUCH W/ACCUSEAL TAP

    MDR report key: 4133011 · Received September 29, 2014

    Report

    Report Number
    9618003-2014-11190
    Event Type
    Malfunction
    Date Received
    September 29, 2014
    Report Date
    December 14, 2012
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC, INC.
    Product Code
    EXH
    PMA / PMN Number
    K840166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO THE FDA 483 ISSUED 04/16/2014. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ANALYSIS IS TAKEN FROM A TRENDING REPORT OF EVALUATION OR ADVERSE EVENTS FINALIZED 05/2010. IT WAS DETERMINED THAT THE ROOT CAUSE WAS TOO MUCH SILICONE ON THE TAP. THE INVESTIGATION SHOWS THAT THE ISSUE REPORTED AS "URINE WON'T DRAIN FROM POUCH" HAS BEEN CONFIRMED AND ACTIONS HAVE TAKEN PLACE TO ADDRESS IT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THAT URINE WOULD NOT DRAIN. A PIN WAS USED TO TRY AND DRAIN THE URINE, BUT IT DID NOT WORK. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606485 S2S/SUR-FIT NATURA 2 PC - 2 PC UROSTOMY POUCH W/ACCUSEAL TAP URINAR, ILEOSTOMY EXH CONVATEC DOMINICAN REPUBLIC, INC. 401544 2F00527

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK