BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAKIN COHESIVE SEAL LARGE

    MDR report key: 5150546 · Received October 14, 2015

    Report

    Report Number
    9681410-2015-30444
    Event Type
    Injury
    Date Received
    October 14, 2015
    Date of Event
    January 17, 2014
    Report Date
    February 27, 2014
    Manufacturer
    T.G. EAKIN LTD
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL 2015-001-PRO AND PROTOCOL 2015-002-PRO. 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). EVALUATION CONCLUSIONS ARE REFLECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT END USER REACTED TO EAKIN. RED AND WEEPING IN AREA THAT EAKIN WAS IN CONTACT WITH THE SKIN. CLIENT HAD USED THE PRODUCT X 1 YEAR AND REACTED LAST MONTH. WENT TO THE HOSPITAL AND AREA LEFT TO AIR. EAKIN REMOVED OUT OF CARE AND REDNESS HEALED UP. AQUACEL AND COVER DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679347 EAKIN COHESIVE SEAL LARGE PROTECTOR, OSTOMY EXE T.G. EAKIN LTD 839001 1093577095

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention