BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAKIN COHESIVE SEAL SMALL

    MDR report key: 5289016 · Received December 11, 2015

    Report

    Report Number
    9681410-2015-40094
    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
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL 2015-003-PRO AND PROTOCOL 2015-004-PRO. 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 WHEN TRYING TO REMOVE THE WAFER A SMALL AREA OF SKIN WAS TORN OFF ALSO. THE TORN SKIN WAS APPROX 2 INCHES WIDE AT 6 OCLOCK. STATES THE EAKIN WAS VERY DIFFICULT TO REMOVE. HAS APPLIED SAFE AND SIMPLE NO STING WIPES BEFORE APPLYING EAKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820860 EAKIN COHESIVE SEAL SMALL PROTECTOR, OSTOMY EXE T.G. EAKIN LTD. 839002

    Patients

    Seq Age Sex Outcome Treatment
    1