BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2 PC-DURAHESIVE MOLDABLE WAFER

    MDR report key: 3940289 · Received June 19, 2014

    Report

    Report Number
    1049092-2014-00223
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 23, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K830945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BA A SERIOUS INJURY. IT IS REPORTED THAT END-USER IS TRIALING FULL DURAHESIVE SKIN BARRIER. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE END-USER DEVELOPED AN ITCHY, FLAT, DRY, RED RASH MOSTLY UNDER THE TAPE BORDER THAT STARTED ABOUT ONE (1) MONTH AGO. IT IS REPORTED THAT THE RASH WAS TREATED WITH NYSTATIN POWDER WITHOUT IMPROVEMENT, HOWEVER A CHANGE FROM A BARRIER WIPE WITH ALCOHOL TO THE SENSICARE BARRIER WIPE DID PROVIDE A SLIGHT IMPROVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360933 SUR-FIT NATURA 2 PC-DURAHESIVE MOLDABLE WAFER PROTECTOR, OSTOMY 78EXE EXE CONVATEC INC. 411802 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention