BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVELIFE 1PC DRAINABLE POUCH W/STOMAHESIVE

    MDR report key: 3883647 · Received June 9, 2014

    Report

    Report Number
    9618003-2014-00053
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EZQ
    PMA / PMN Number
    K833625
    Adverse Event
    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 SERIOUS INJURY. THE END USER STATED SHE CLEANSES HER SKIN SURROUNDING HER FISTULA WITH WATER, APPLIES PRESCRIPTION NYSTOP POWDER TO THE REDDENED AREA FOLLOWED BY SMITH AND NEPHEW NO STING PROTECTIVE BARRIER. THE END USER STATED SHE HAS TRIED APPLYING CALMOSEPTINE, DESITIN, ALGICELL TO THE REDDENED AREA, BUT THE REDNESS HAS PERSISTED. THE END USER ALSO STATED SHE HAS BEEN EXPERIENCING THIS REDNESS ON AND OFF SINCE (B)(6) 2012. THE END USERS OSTOMY NURSE RECOMMENDED A DIFFERENT WAFER WHICH THE END USER STATED SHE PLANS ON TRYING ONCE SHE RECEIVES THE SAMPLES. THE END USER ALSO STATED SHE HAS USED SUCTION TO HER FISTULA WHICH HELPS RESOLVE THE REDNESS, BUT SHE STATED SHE IS UNABLE TO DO THIS LONG TERM. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. REPORTED TO THE FDA ON (B)(6), 2014.

    Description of Event or Problem · 1

    AN END USER REPORTED SHE IS EXPERIENCING REDNESS AROUND HER FISTULA FROM THE 3 TO 9 O'CLOCK POSITION, WHICH SHE STATED EXTENDS OUTWARD APPROXIMATELY 25MM. THE END USER WENT ON TO STATE SHE DOES EXPERIENCE A BURNING SENSATION FROM THIS REDDENED SKIN WHEN HER FISTULA FUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334094 ACTIVELIFE 1PC DRAINABLE POUCH W/STOMAHESIVE POUCH, COLOSTOMY EZQ CONVATEC INC. 022771 4A03691

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention