BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAKIN COHESIVE SEAL SMALL

    MDR report key: 5155566 · Received October 16, 2015

    Report

    Report Number
    9681410-2015-30609
    Event Type
    Malfunction
    Date Received
    October 16, 2015
    Report Date
    February 27, 2014
    Manufacturer
    T.G. EAKIN LTD.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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

    PATIENT REPORTS THAT SHE IS CURRENTLY USING A TWO PIECE PRODUCT ALONG WITH AN EAKIN COHESIVE SEAL. SHE DESCRIBES THE EAKIN COHESIVE SEAL IS DIFFICULT TO REMOVE AT TIMES. SHE IS CURRENTLY WASHING WITH IVORY SOAP; APPLYING SAFE AND SIMPLE SKIN PROTECTIVE BARRIER; ADAPT POWDER; EAKIN AND THEN THE WAFER. THE END USER DID NOT HAVE THE BOX. THEREFORE THE LOT NUMBER COULD NOT BE PROVIDED. PRODUCT USE AND SKIN CARE INSTRUCTIONS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686079 EAKIN COHESIVE SEAL SMALL PROTECTOR, OSTOMY EXE T.G. EAKIN LTD. 839002

    Patients

    Seq Age Sex Outcome Treatment
    1