BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2 PC DURAHESIVE MOLDABLE WAFER

    MDR report key: 3911622 · Received May 28, 2014

    Report

    Report Number
    1049092-2014-00155
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    January 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. REPORT STATES THAT END-USER HAS HAD EIGHT (8) VISITS WITH MULTIPLE HEALTH CARE PROVIDERS TO INCLUDE PRIMARY PHYSICIAN; UROLOGIST AND INFECTIOUS DISEASE PHYSICIAN. A DERMATOLOGY REFERRAL WAS RECOMMENDED AS WELL AS A TRIAL OF CONVEXITY AND HOW TO CRUST USING HIS PRESCRIBED (B)(4) POWDER. ALSO RECOMMENDED VINEGAR SOAKS DURING POUCH CHANGE. REPORTS UROLOGIST HAS PRESCRIBED (B)(4) POWDER WITHOUT IMPROVEMENT; PRIMARY PHYSICIAN HAS ALSO PRESCRIBED CLOTRIMAZOLE AND BETAMETHASONE CREAM; INFECTIOUS DISEASE PHYSICIAN HAS PRESCRIBED ARGALAES. END-USER WAS PREVIOUSLY ADVISED TO RESIZE BARRIER WHICH HE DID WITHOUT SUCCESS. LASTLY, SAMPLES WERE SENT TO END-USER. NO ADDITIONAL PATIENT/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.

    Additional Manufacturer Narrative · 1

    AFTER DETAILED BATCH REVIEW, A DISCREPANCY WAS NOTED THAT WAS UNRELATED TO THIS COMPLAINT. A NON-CONFORMANCE WAS RAISED FOR THIS DISCREPANCY AND THERE IS NO IMPACT TO THIS COMPLAINT. THE PRODUCT ASSOCIATED WITH BATCH 3K00812 WAS MADE ACCORDING TO SPECIFICATION. THE QUALITY SYSTEM WAS QUERIED FOR ANY NON-CONFORMANCES OR DEVIATIONS AGAINST THE LOTS ASSOCIATED WITH FINAL BATCH 3K00812. THE RESULTS SUPPORT THAT NO NON-CONFORMANCES WERE RAISED AGAINST THIS BATCH FOR THIS COMPLAINT ISSUE. 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).

    Description of Event or Problem · 1

    IT IS REPORTED THAT END-USER DEVELOPED A RED RASH AROUND THE STOMA WHICH THE END-USER HAS HAD FOR MONTHS AND WAS DIAGNOSED AS FUNGAL RASH WITH BLEEDING AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314206 SUR-FIT NATURA 2 PC DURAHESIVE MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC INC. 411801 3K00812

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention