BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUR-FIT NATURA UROSTOMY POUCH W/ACCUSEAL TAP W/VLAVE OPAQUE STANDARD W/1-SIDED C

    MDR report key: 4147910 · Received October 1, 2014

    Report

    Report Number
    9618003-2014-10844
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    August 2, 2012
    Manufacturer
    CONVATEC DOM. REPUBLIC, INC.
    Product Code
    EXH
    PMA / PMN Number
    K840166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 MFG PROCESS. CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO THE FDA 483 ISSUED APRIL 16, 2014. DEVICE (S) LIST IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADD'L INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ANALYSIS IS TAKEN FROM A TRENDING REPORT OF EVAL OR ADVERSE EVENTS FINALIZED MAY 2011. THE DATA PRESENTED IS FROM THREE DIFFERENT PRODUCT APPLICATIONS. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS. BRAND NAME: SUR-FIT NATURA UROSTOMY POUCH W/ACCUSEAL TAP W/VLAVE OPAQUE STANDARD W/1-SIDED COMFORT PANEL.

    Description of Event or Problem · 1

    THE PT REPORTED HE COULD NOT DRAIN THE URINE FROM THE POUCH VIA THE TAP. THIS ISSUE OCCURRED WITH 5 OF THE 10 POUCHES IN THE BOX. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611552 SUR-FIT NATURA UROSTOMY POUCH W/ACCUSEAL TAP W/VLAVE OPAQUE STANDARD W/1-SIDED C BAG, URINARY, ILEOSTOMY EXH CONVATEC DOM. REPUBLIC, INC. 401553 2C00119

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK