BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA STOMAHESIVE FLEXIBLE 4" X 4" WAGER

    MDR report key: 4963013 · Received July 31, 2015

    Report

    Report Number
    1049092-2015-00449
    Event Type
    Injury
    Date Received
    July 31, 2015
    Report Date
    July 27, 2015
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO ADDITIONAL DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE END USER DEVELOPED CIRCUMFERENTIAL PERISTOMAL REDNESS ALONG WITH SLIGHT ITCHING UNDER THE WHITE TAPE COLLAR OF THE SKIN BARRIER. THE REDNESS AND ITCHING HAS PERSISTED FOR MORE THAN 6 MONTHS. THE END USER WAS ADVISED TO APPLY AN OVER-THE-COUNTER ANTIFUNGAL POWDER TO THE AREA PRIOR TO THE APPLICATION OF THE SKIN BARRIER. THE END USER SAW HIS DOCTOR ON (B)(6) 2015 WHO PRESCRIBED A PRESCRIPTION STRENGTH STEROID CREAM BE APPLIED TO THE AFFECTED AREA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499111 NATURA STOMAHESIVE FLEXIBLE 4" X 4" WAGER PROTECTOR, OSTOMY EXE CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. 125259

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention MULTIPLE ANTIBIOTICS