BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAKIN COHESIVE SEAL SLIM

    MDR report key: 5288989 · Received December 11, 2015

    Report

    Report Number
    9681410-2015-40087
    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
    CA, 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 CIRCUMFERENTIAL PERISTOMAL REDNESS UNDER THE EAKIN COHESIVE SEAL. REPORTS EFFLUENT STARTS TO OOZE UNDER EAKIN COHESIVE SEAL WITHIN HOURS OF APPLICATION CAUSING THIS PERISTOMAL REDNESS. HE ALSO REPORTS EAKIN SEALS ARE DIFFICULT TO REMOVE AND THAT 1 WAS SO DIFFICULT TO REMOVE THAT HE STRIPPED HIS SKIN WHEN REMOVING IT AND AS A RESULT HE HAD A SMALL AMOUNT OF BLEEDING FROM THIS AREA. NO BLEEDING NOTED AT THIS TIME. HE SAID HE IS UNABLE TO USE ANY SH POWDER. INSTRUCTED ON CLEANSING HIS PERISTOMAL SKIN WITH WATER AND MILD SOAP; ONE WITHOUT LOTIONS; MOISTURIZERS OR CREAMS. INSTRUCTED IF AREA DOES NOT IMPROVE OR HE HAS ANY QUESTIONS TO CONTACT US FOR ADDITIONAL INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820650 EAKIN COHESIVE SEAL SLIM PROTECTOR, OSTOMY EXE T.G. EAKIN LTD. 839005 1093576627

    Patients

    Seq Age Sex Outcome Treatment
    1 LANSOPRAZOLE