BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUR-FIT NATURA 2 PC UROSTOMY POUCH W/FOLD FLAP

    MDR report key: 3970603 · Received June 2, 2014

    Report

    Report Number
    9618003-2014-00050
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    EXH
    PMA / PMN Number
    K840166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WAS NO HARM TO THE PT REPORTED. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 23, 2015. NO PREVIOUS INVESTIGATIONS ARE AVAILABLE. AFTER A THOROUGH BATCH REVIEW, NO DISCREPANCIES WERE FOUND. THERE IS NOT ENOUGH INFORMATION TO CONCLUDE THE PRODUCT DID NOT MEET SPECIFICATION AND PERFORM AS INTENDED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. NO FURTHER ACTIONS ARE REQUIRED, AND THE COMPLAINT WILL BE CLOSED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PHARMACIST REPORTED THE POUCH FILM STUCK TOGETHER WHICH PREVENTED URINE FROM FILLING INTO POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320931 SUR-FIT NATURA 2 PC UROSTOMY POUCH W/FOLD FLAP URINARY, ILEOSTOMY, 78EXH EXH CONVATEC INC 401535 3J01061

    Patients

    Seq Age Sex Outcome Treatment
    1