BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2 PC DURAHESIVE CONVEX WAFER

    MDR report key: 4100883 · Received September 12, 2014

    Report

    Report Number
    1049092-2014-00476
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 29, 2014
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH BATCH 3J01986 WAS MADE ACCORDING TO SPECIFICATION. AFTER DETAILED BATCH REVIEW, NO DISCREPANCIES (INCLUDES NON-CONFORMANCES/DEVIATIONS) WERE FOUND. THIS COMPLAINT IS NOT ASSOCIATED WITH A PRODUCT MALFUNCTION. THE COMPLAINT/INCIDENCE DATA-POST MARKET DATA ANALYSIS (TREND ANALYSIS), CLINICAL REVIEW, ROOT CAUSE ANALYSIS AND RISK ASSESSMENT INDICATE A CONSISTENT RATE OF COMPLAINTS AS A RESULT OF SKIN COMPLICATIONS WHICH ARE 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. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, THIS CASE IS CONSIDERED A SERIOUS INJURY. END USER REPORTS REQUIRING A CONVEX WAFER. CONVATEC DOES NOT HAVE CONVEX WAFERS WITHOUT A TAPE BORDER. THE END USER IS GOING TO CUT THE ADHESIVE BORDER OFF HER NEXT WAFER. SHE WAS INSTRUCTED IN SKIN CARE AND THE CRUSTING TECHNIQUE USING STOMAHESIVE POWDER AND A PROTECTIVE SKIN BARRIER. END USER WILL BE SENT SAMPLES OF BOTH. IN ADDITION, THE END USER ALSO REPORTS SHE HAS HAD A FUNGAL RASH AND USING A PRESCRIPTION ANTIFUNGAL POWDER FOR THE PAST MONTH WITHOUT RESULTS. END USER WAS INSTRUCTED TO GO BACK TO HER PHYSICIAN. END USER STATES THAT SHE IS SCHEDULED FOR A SECOND OPINION NEXT MONTH. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE END USER REPORTS A RED RASH UNDER THE ADHESIVE TAPE BORDER ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566102 SUR-FIT NATURA 2 PC DURAHESIVE CONVEX WAFER PROTECTOR, OSTOMY EXE CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. 413182 3J01906

    Patients

    Seq Age Sex Outcome Treatment
    1