BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAKIN COHESIVE SEAL SMALL

    MDR report key: 5289457 · Received December 11, 2015

    Report

    Report Number
    9681410-2015-40080
    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
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION (B)(4).

    Description of Event or Problem · 1

    COMPLAINANT REPORTS "APPLIED SEAL FROM NEW BOX AND WITHIN HALF HOUR SHE DEVELOPED ABDOMINAL GAS PAINS AND BLOATING, AND HER TONGUE SWELLED. SHE REMOVED WAFER, POUCH, AND EAKIN. APPLIED EAKIN FROM PREVIOUS BOX WITH DIFFERENT LOT NUMBER ALONG WITH NEW WAFER AND POUCH. STATES ISSUE RESOLVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818526 EAKIN COHESIVE SEAL SMALL PROTECTOR, OSTOMY EXE T.G. EAKIN LTD 839002 6597

    Patients

    Seq Age Sex Outcome Treatment
    1