BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAKIN COHESIVE SEAL SMALL

    MDR report key: 5138801 · Received October 8, 2015

    Report

    Report Number
    9681410-2015-30377
    Event Type
    Injury
    Date Received
    October 8, 2015
    Date of Event
    November 1, 2013
    Report Date
    February 27, 2014
    Manufacturer
    T.G. EAKIN LTD
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    CUSTOMER CALLED REGARDING EAKIN SEAL AND THAT SHE WAS HAVING LEAKAGE AND BLEEDING TO SKIN AFTER SEVERAL WAFER CHANGES. SPOKE WITH ENDUSER AND SHE REPORTS THAT SHE STARTED USING NEW SHIPMENT OF EAKIN SEALS FRIDAY AND NOTED THEY ARE WHITE IN COLOR; THINNER; SOFTER; AND ALMOST GRANULAR LOOKING. SHE HAD TO CHANGE WAFER AT LEAST 6 TIMES IN 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667375 EAKIN COHESIVE SEAL SMALL PROTECTOR, OSTOMY EXE T.G. EAKIN LTD 839002 1093577358

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention