BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAKIN COHESIVE SEAL SLIM

    MDR report key: 5157258 · Received October 16, 2015

    Report

    Report Number
    9681410-2015-30496
    Event Type
    Injury
    Date Received
    October 16, 2015
    Date of Event
    May 5, 2014
    Report Date
    February 27, 2014
    Manufacturer
    T.G. EAKIN LTD
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A). EVALUATION CONCLUSIONS ARE REFLECTED IN THE CODES.

    Description of Event or Problem · 1

    END USER REPORTS WHEN AN (B)(4) COHESIVE SEAL WAS REMOVED IT PULLED OFF A SMALL PIECE OF HER PERISTOMAL SKIN. THIS OCCURRED ON THE RIGHT SIDE OF HER STOMA. SHE DESCRIBES IT BEING ABOUT THE SIZE OF A BABY'S FINGERNAIL. THIS HAPPENED YESTERDAY. SHE HAS CLEANED THE AREA WITH SOAP AND WATER; APPLIED A STOMAHESIVE STRIP AND THEN THE WAFER. SHE IS ALLERGIC TO STOMAHESIVE POWDER BUT NOT THE STOMAHESIVE STRIPS. SHE IS CURRENTLY USING A COMPETITORS TWO PIECE SYSTEM AND IS NOT INTERESTED IN CHANGING AT THIS TIME. SHE WAS INSTRUCTED TO CALL BACK WITH ANY CONCERNS OR QUESTIONS. SAMPLES OF THE SH SKIN BARRIER WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686478 EAKIN COHESIVE SEAL SLIM PROTECTOR, OSTOMY EXE T.G. EAKIN LTD 839005

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention