BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA PC DURAHESIVE CONVEX WAFER

    MDR report key: 3550488 · Received December 26, 2013

    Report

    Report Number
    1049092-2013-00405
    Event Type
    Injury
    Date Received
    December 26, 2013
    Date of Event
    July 15, 2013
    Report Date
    December 3, 2013
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    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 A SERIOUS INJURY. IT IS REPORTED THAT END-USER USES STOMAHESIVE (SH) PASTE TO HER PERISTOMAL SKIN. SHE USES (B)(4) POWDER TO HER ENTIRE PERISTOMAL SKIN INCLUDING WHERE THE REDNESS IS LOCATED. SHE CLEANSES HER PERISTOMAL SKIN WITH (B)(4) SOAP. SHE DID HAVE SOME REDNESS TO HER UMBILICAL AREA UNDER THE WHITE TAPE COLLAR BUT THIS REDNESS HAS RESOLVED. REDNESS UNDER THE MASS IS INTERMITTENT AND HAS BEEN SO SINCE APPROXIMATELY (B)(6) 2013. CURRENTLY, SHE APPLIES (B)(4) POWDER TO THE REDNESS. SHE DID TRY CLEANSING THE REDDENED AREA TO HER UMBILICAL AREA WITH HYDROGEN PEROXIDE AND THEN SHE WOULD APPLY NEOSPORIN TO THE AREA. REDNESS TO UMBILICAL AREA HAS RESOLVED. THE END USER WAS INSTRUCTED ON CRUSTING WITH (B)(4) POWDER FOLLOWED BY PROTECTIVE BARRIER WIPES OR WATER. ESTEEM SYNERGY MOLDABLE CONVEX SKIN BARRIER WAS RECOMMENDED SINCE IT IS MORE FLEXIBLE AT THE EDGE OF THE MASS. THE END USER WAS ALSO INSTRUCTED TO CALL BACK IF CONDITION WORSENED OR DOES NOT IMPROVE. NO ADD'L PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADD'L INFO BECOMES AVAILABLE, A F/U REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH BATCH 2K03169 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 NON-CONFORMANCE IS APPLICABLE TO THIS COMPLAINT AND IS CLOSED. NO FURTHER ACTIONS ARE REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. THE COMPLAINT/INCIDENCE DATA-POST MARKET ANALYSIS (TREND ANALYSIS), CLINICAL REVIEW, ROOT CAUSE ANALYSIS AND RISK ASSESSMENT INDICATE A CONSISTENT RATE OF COMPLAINTS BY THE END USER IS 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 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

    ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 23, 2015. THE PRODUCT ASSOCIATED WITH LOT# 2K03169 WAS MANUFACTURED ACCORDING TO SPECIFICATION. AFTER A THOROUGH BATCH REVIEW, NO DISCREPANCIES, NON-CONFORMANCES OR DEVIATION WERE FOUND. THERE IS NOT ENOUGH INFORMATION TO CONCLUDE THE PRODUCT DID NOT MEET SPECIFICATION AND PERFORM AS INTENDED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. PREVIOUS INVESTIGATION, IS APPLICABLE TO THIS COMPLAINT INVESTIGATION. THEREFORE, THIS COMPLAINT WILL REMAIN OPEN UNTIL COMPLETION OF THE PREVIOUS INVESTIGATION. 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

    END USER REPORTS CIRCUMFERENTIAL SCATTERED REDNESS AT THE EDGE OF THE MASS WHICH EXTENDS INWARD APPROXIMATELY 7MM. IT OCCURS UNDER THE MASS AND WHITE TAPE COLLAR. THIS REDNESS IS THE WORST AT THE PROXIMAL END APPROXIMATELY 1000-200 O'CLOCK. SHE DOES EXPERIENCE SOME ITCHING FROM THIS AREA ESPECIALLY AFTER SHE EXERCISES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675570 SUR-FIT NATURA PC DURAHESIVE CONVEX WAFER PROTECTOR, OSTOMY EXE CONVATEC INC. 413181 2K03169

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention