BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUR-FIT NATURA 2PC DRAINABLE POUCH INVISICLOSE

    MDR report key: 3897203 · Received May 21, 2014

    Report

    Report Number
    9618003-2014-00049
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    CONVATEC, INC.
    Product Code
    EZQ
    PMA / PMN Number
    K833625
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. NO RETURNED PRODUCT WAS RECEIVED TO ALLOW FOR A FULL INVESTIGATION INTO THE CUSTOMER COMPLAINT. THERE WERE NO DISCREPANCIES NOTED IN THE BATCH RECORD RELATED TO THE REPORTED COMPLAINT ISSUE. THE BATCH RECORD REVIEW INDICATES ALL REQUIRED IN PROCESS CHECKS AND TESTING WAS CORRECTLY CARRIED OUT. THE RETAIN SAMPLES OF LOT RECEIVED SPEC. ALL LABELS WERE EVIDENT AND CORRECT AND CORRESPOND WITH THE DISRUPTION OF THE PRODUCT IN QUESTION, ALL RETAIN SAMPLE POUCH FLANGES MEASURED (B)(4) AS PER SPEC. THEREFORE BASED UPON THE EVIDENCE PROVIDED THIS COMPLAINT IS NOT CONFIRMED. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE A F/U REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. THIS MDR IS BEING REPORTED AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINT RECORDS CONDUCTED BY CONVATEC FOR COMPLAINTS RECEIVED FROM (B)(4) 2011 - (B)(4) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE (1) OUT OF TEN (10) POUCHES IN THE BOX, ONE POUCH WAS NOTED TO HAVE A 2 1/4 INCH FLANGE, WHICH WAS STATED TO BE THE WRONG PRODUCT IN THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303421 SUR-FIT NATURA 2PC DRAINABLE POUCH INVISICLOSE POUCH, COLOSTOMY, 78EZQ EZQ CONVATEC, INC. 411310 0H00087

    Patients

    Seq Age Sex Outcome Treatment
    1