BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVELIFE 1PC UROSTOMY POUCH W/DURAHESIVE

    MDR report key: 3912928 · Received May 14, 2014

    Report

    Report Number
    1049092-2014-00111
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXH
    PMA / PMN Number
    K780454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. ADDITIONAL PATIENT/EVENT INFORMATION WAS REQUESTED ON (B)(4) 2014. PLEASE NOTE: DESC OF EVENT REFERENCES - ISSUE OCCURRED ON TEN (10) SEPARATE CASES. A SEPARATE 3500A FORM HAS BEEN COMPLETED FOR THE OTHER (9) CASES UNDER PATIENT IDENTIFIER #(S) (B)(6). MANUFACTURER REPORT#(S): 1049092-2014-00108, 1049092-2014-00109, 1049092-2014-00110, 1049092-2014-00112, 1049092-2014-00113, 1049092-2014-00114, 1049092-2014-00115, 1049092-2014-00116 AND 1049092-2014-00117 RESPECTIVELY. (REPORT 4 OF 10). NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW- UP REPORT WILL BE SUBMITTED. NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON SEPTEMBER 08, 2015. NO PREVIOUS INVESTIGATIONS ARE AVAILABLE. AFTER THOROUGH BATCH REVIEW, NO DISCREPANCIES (INCLUDES NON-CONFORMANCES/DEVIATIONS) 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. (B)(4).

    Description of Event or Problem · 1

    END USER REPORTS URINE WILL NOT DROP BELOW ANTI REFLUX VALVEY IN 10 POUCHES. IT WAS REPORTED THAT THIS ISSUE OCCURRED ON (TEN) SEPARATE CASES. FOR RELATED PATIENT IDENTIFIERS AND MANUFACTURER REPORT NUMBERS). (REPORT 4 OF 10)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288123 ACTIVELIFE 1PC UROSTOMY POUCH W/DURAHESIVE URINARY, ILEOSTOMY EXH CONVATEC, INC. 650831 3G01617

    Patients

    Seq Age Sex Outcome Treatment
    1