BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2 PC DURAHESIVE WAFER

    MDR report key: 4100892 · Received September 12, 2014

    Report

    Report Number
    1049092-2014-00469
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    July 27, 2014
    Report Date
    August 27, 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
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE END-USER WAS SEEN BY THE WOUND, OSTOMY AND CONTINENCE NURSE (WOCN) AND TREATED WITH TINACTIN (TOLNAFTATE) AND AN UNKNOWN SKIN PREP FOR ONE AND ONE-HALF (1 1/2) WEEKS. THE END-USER USES (B)(6) SOAP. NO IMPROVEMENT WAS SEEN. A SHOWER, STOMAHESIVE POWDER, AND A PROTECTIVE SKIN BARRIER WERE DISCUSSED WITH THE END-USER. HE WAS REFERRED TO A DERMATOLOGIST. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH BATCH 4B02924 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).

    Description of Event or Problem · 1

    THE END-USER REPORTED HE DEVELOPED A RED, WEEPY RASH IN THE PUBIC AREA AND UNDER SEVENTY PERCENT OF THE LOWER WAFER WHILE VISITING THE (B)(6) FOR A MONTH. HE REPORTED THE ITCHING OCCURS ONLY IN THE PUBIC AREA AND NOT UNDER THE WAFER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566101 SUR-FIT NATURA 2 PC DURAHESIVE WAFER PROTECTOR, OSTOMY EXE CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. 413156 4B02924

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R