BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUR-FIT NATURA UROSTOMY POUCH W/ACCUSEAL TAP W/VALVE TRANSPARENT STANDARD W/1-SI

    MDR report key: 4148455 · Received October 2, 2014

    Report

    Report Number
    9618003-2014-11528
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Report Date
    April 10, 2013
    Manufacturer
    CONVATEC DOM. REPUBLIC, INC.
    Product Code
    EXH
    PMA / PMN Number
    K840166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION INTO AN INCREASE OF COMPLAINTS REGARDING A BLOCKED TAP WAS PERFORMED. ANALYSIS OF THOSE COMPLAINTS FOUND THE ROOT CAUSE OF THE EVENT WAS AN EXCESS AMOUNT OF SILICONE APPLIED TO THE TAP DURING THE MANUFACTURING PROCESS. CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF THE REMEDIATION ACTIVITIES RELATED TO THE FDA 483 ISSUED APRIL 16, 2014. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THE END USER COULD NOT DRAIN URINE FROM THE POUCH VIA THE TAP. TWO OF THE 10 POUCHES IN THE BOX WERE IMPACTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615466 SUR-FIT NATURA UROSTOMY POUCH W/ACCUSEAL TAP W/VALVE TRANSPARENT STANDARD W/1-SI BAG, URINARY, ILEOSTOMY EXH CONVATEC DOM. REPUBLIC, INC. 401545 2L00358

    Patients

    Seq Age Sex Outcome Treatment
    1