BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUR-FIT PLUS TWO-PIECE UROSTOMY POUCH W/ACCUSEAL TAP

    MDR report key: 4148454 · Received October 2, 2014

    Report

    Report Number
    9618003-2014-11545
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    CONVATEC DOM. REPUBLIC, INC.
    Product Code
    EXH
    PMA / PMN Number
    K840166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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 VALVE ON THE UROSTOMY POUCH IS NOT WORKING PROPERLY AND PREVENTED THE USER FROM DRAINING URINE FROM THE POUCH. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615334 SUR-FIT PLUS TWO-PIECE UROSTOMY POUCH W/ACCUSEAL TAP BAG, URINARY, ILEOSTOMY EXH CONVATEC DOM. REPUBLIC, INC. 402555 2B02690

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK