BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA STOMAHESIVE FLEXIBLE 5" X 5" WAFER

    MDR report key: 4852517 · Received June 17, 2015

    Report

    Report Number
    1049092-2015-00347
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    January 1, 2015
    Report Date
    June 8, 2015
    Manufacturer
    CONVATEC, INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO ADDITIONAL PATIENT/ EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE A F/U REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS COMPLAINT INVESTIGATION WAS MADE ACCORDING TO SPECIFICATION. AFTER DETAILED BATCH REVIEW, NO DISCREPANCIES, INCLUDING NON-CONFORMANCES/DEVIATIONS, WERE FOUND. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. PREVIOUS APPLICABLE NONCONFORMANCE(NC) INVESTIGATION HAS BEEN COMPLETED. THE INVESTIGATION REVEALED THAT THE COMPLAINT/INCIDENCE DATA-POST MARKET DATA ANALYSIS (TREND ANALYSIS), CLINICAL REVIEW, ROOT CAUSE ANALYSIS AND RISK ASSESSMENT INDICATE A CONSISTENT RATE OF COMPLAINTS BY THE END USER AS A RESULT OF SKIN COMPLICATIONS CAUSED BY A VARIETY OF EXTERNAL FACTORS NOT RELATED TO THE DESIGN, MATERIALS, AND/OR PROCESSES OF THE PRODUCT. NO FURTHER ACTIONS ARE REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE END USER DEVELOPED AN ITCHY, RED RASH UNDER THE TAPE COLLAR OF SKIN BARRIER APPROX 5-6 MONTHS AGO. THE PATIENT SOUGHT TREATMENT FROM A DERMATOLOGIST AND WAS PRESCRIBED TRIAMCINOLONE CREAM 0.1 PERCENT TO APPLY TOPICALLY TO THE AFFECTED AREA. IN ADDITION, THE END USER HAS REMOVED THE TAPE COLLAR PRIOR TO APPLYING THE SKIN BARRIER. THE RASH HAS IMPROVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394604 NATURA STOMAHESIVE FLEXIBLE 5" X 5" WAFER PROTECTOR, OSTOMY EXE CONVATEC, INC 125265 5A03406

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention PRADAXA