BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAKIN FISTULA AND WOULD PCHES

    MDR report key: 4203244 · Received October 23, 2014

    Report

    Report Number
    1000317571-2014-00101
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 20, 2014
    Manufacturer
    CONVATEC LIMITED
    Product Code
    FON
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. END USER'S HOME HEALTH NURSE SWITCHED HER POUCHING PRODUCT TO A SOLID STOMAHESIVE WAFER AND POUCH AND HAS USED THE STOMAHESIVE POWDER TO HELP DRY THE SKIN. DISCUSSED POSSIBLE CANDIDIASIS. SHE WILL CALL HER DOCTOR ABOUT AN ANTI-FUNGAL POWDER. ALSO, DISCUSSED HOW TO PATCH TEST FOR SENSITIVITY TO OTHER PRODUCTS BEING USED. END USER REPORTS ACCESSORIES IN USE INCLUDE TINCTURE OF BENZOIN, SKIN PREP BY (B)(4), EAKIN SEAL AND STOMAHESIVE POWDER. NO ADD'L PT/EVENT DETAILS HAS BEEN PROVIDED TO DATE. NO SAMPLE IS EXPECTED TO BE RETURNED. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE END USER OBSERVED A RED RASH EXTENDING BEYOND AND BELOW THE MASS OF THE POUCH AFTER USING THE PRODUCT APPROXIMATELY TWO MONTHS. THERE ARE SMALL RED BUMPS ALONG THE OUTER EDGE AND THE RASH IS MOIST AND ITCHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677225 EAKIN FISTULA AND WOULD PCHES BAG, DRAINAGE WITH ADHESIVE, OSTOMY FON CONVATEC LIMITED 839262 7820

    Patients

    Seq Age Sex Outcome Treatment
    1