BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT 2 PC DURAHESIVE MOLDABLE WAFER

    MDR report key: 4132804 · Received September 29, 2014

    Report

    Report Number
    1049092-2014-00504
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 12, 2014
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ASSOCIATED WITH BATCH (B)(4) 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. REPORTED TO THE FDA ON APRIL 1, 2016. (B)(4)

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A SERIOUS INJURY. END USER REPORTS SEEING LOCAL WOUND OSTOMY CONTINENCE NURSE ON (B)(6) 2014. END USER REPORTS TRYING A PRESCRIPTION ANTIFUNGAL POWDER (NAME UNKNOWN) WITH NO IMPROVEMENT, AND THEN STARTED ORAL PREDNISONE FOR TWO WEEKS WITH IMPROVEMENT. SAMPLES OF THE ACRYLIC TAPE COLLAR WAFERS WERE PROVIDED WITHOUT ANY FURTHER ISSUES OF WEEPING OR ITCHING REPORTED BY THE 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.

    Description of Event or Problem · 1

    IT IS REPORTED BY END USER A ONE WEEK HISTORY OF ITCHY, RED BUMPY RASH UNDER THE TAPE COLLAR WAFER ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607174 SUR-FIT 2 PC DURAHESIVE MOLDABLE WAFER EXE CONVATEC, INC. 411802 4F00281

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention