BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAKIN COHESIVE SEAL SMALL

    MDR report key: 5290054 · Received December 11, 2015

    Report

    Report Number
    9681410-2015-40088
    Event Type
    Injury
    Date Received
    December 11, 2015
    Report Date
    November 6, 2015
    Manufacturer
    T.G. EAKIN LTD.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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).

    Description of Event or Problem · 1

    END-USER REPORTS THAT ABOUT 2 MONTHS AGO HE NOTICED A CHANGE IN THE EAKIN SEALS HE WAS USING THE MASS WAS BREAKING DOWN IN LESS THAN A DAY LEADING TO LEAKAGE AND FREQUENT APPLIANCE CHANGES HE REPORTS THAT THE SKIN UNDER THE ENTIRE AREA COVERED BY THE SEAL IS RED WEEPING AND BLEEDING A LITTLE AT EVERY CHANGE HE STATES "I THINK I AM ALLERGIC TO THE EAKIN SEAL NOW".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820028 EAKIN COHESIVE SEAL SMALL PROTECTOR, OSTOMY EXE T.G. EAKIN LTD. 839002 1093576719

    Patients

    Seq Age Sex Outcome Treatment
    1 ALEVE