BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTEEM SYNERGY 2OC DURAHESIVE MOLDABLE WAFER

    MDR report key: 3775831 · Received April 18, 2014

    Report

    Report Number
    1049092-2014-00096
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    March 23, 2014
    Report Date
    March 25, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 CONFIRMED THAT PRODUCT LOT NUMBER UNAVAILABLE AND IRRETRIEVABLE. THE END USER REPORTS SHE HAS BEEN USING THIS WAFER FOR ONE AND ONE HALF YEARS. THE END USER REPORTED THAT SHE IS USING STOMAHESIVE POWDER; AQUACEL HYDROFIBER AND THIN DUODERM TO COVER ULCER PRIOR TO PLACING HER SKIN BARRIER. SHE FURTHER INFORMED THAT SHE HAS DEVELOPED A PERISTOMAL HERNIA. SHE INFORMED THAT SHE IS NOT WEARING A HERNIA SUPPORT BELT, BUT DOES OWN ONE. THE END USER WAS ADVISED TO STOP USING CONVEXITY AND REPLACE WITH A FLAT SKIN BARRIER USING EAKIN COHESIVE SEAL. SHE WAS FURTHER ADVISED TO WEAR A HERNIA SUPPORT BELT. 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

    END USER REPORTS ULCER DEVELOPING UNDER SKIN BARRIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238670 ESTEEM SYNERGY 2OC DURAHESIVE MOLDABLE WAFER PROTECTOR, OSTOMY, 78EXE EXE CONVATEC INC. 409270 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention