BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA 2 PC - DURAHESIVE (DH) FLEXIBLE WAFER

    MDR report key: 3946296 · Received July 7, 2014

    Report

    Report Number
    1049092-2014-00273
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    October 1, 2013
    Report Date
    June 12, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH BATCH 4A03476 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 AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. SKIN REGIMEN WAS DISCUSSED WITH END-USER AS FOLLOWS: END-USER USES ADHESIVE REMOVER; DOVE SOAP; STOMAHESIVE POWDER AND STING FREE PROTECTIVE BARRIER WIPES; PRODUCT'S WEARTIME IS 48 HOURS. LASTLY, SAMPLES OF FULL BARRIER WILL BE 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE END-USER DEVELOPED A RED HEAT RASH IN MIRROR IMAGE UNDER PRODUCT'S TAPE COLLAR, WHICH STARTED IN (B)(6) 2013 WHILE USING A HOLLISTER PRODUCT WHICH CONTINUED WITH CONVATEC'S PRODUCT CURRENTLY IN USE BY END-USER. IT IS FURTHER REPORTED THAT END-USER HAS SEEN A WOUND OSTOMY & CONTINENCE NURSE (WOCN) THREE (3) TIMES AND TREATMENT PROVIDED WITH ORAL ANTIBIOTICS, STEROID INHALER PUFFED ONTO RASH AND PRESCRIPTION ANTIFUNGAL POWDER WITH NO IMPROVEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393281 NATURA 2 PC - DURAHESIVE (DH) FLEXIBLE WAFER PROCTECTOR, OSTOMY 78EXE EXE CONVATEC INC. 413160 4A03476

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention