BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA 2PC DH CONVEX MOLDABLE WAFER

    MDR report key: 3862767 · Received May 27, 2014

    Report

    Report Number
    1049092-2014-00145
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON SEPTEMBER 09, 2015. A BATCH RECORD REVIEW WAS PERFORMED AND NO DISCREPANCIES WERE NOTED. A PREVIOUS INVESTIGATION IS APPLICABLE TO THIS COMPLAINT. THIS COMPLAINT WILL REMAIN OPEN UNTIL THE COMPLETION OF THE INVESTIGATION. 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

    THE PRODUCT ASSOCIATED WITH BATCH 4A03272 WAS MADE ACCORDING TO SPECIFICATION. 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. (B)(4). 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 SERIOUS INJURY BASED ON THE PATIENT REQUIRING PRESCRIPTIONS FROM ONCOLOGISTS OF NYSTATIN POWDER AND ORAL DIFLUCONIZOL. IT IS REPORTED THAT PATIENT REMOVES APPLIANCE AND CLEANSES SKIN WITH WARM WATER THEN DRIES; APPLIES NYSTATIN POWER; DUST EXCESS AND APPLIES (B)(6) PROTECTIVE BARRIER OVER TOP AND ALLOWS TO DRY. IN ADDITION, THE PATIENT APPLIES (B)(6) PASTE AND THEN WAFER. LASTLY, IT IS REPORTED THAT PATIENT HAS (B)(6) AND HAS NEVER TRIED THE PRODUCT; HOWEVER, WILL TRY TO USE FOR BETTER PROTECTION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4). 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 WAS REPORTED THAT THE PATIENT THAT HAS HAD RASH IN THE PAST BUT DEVELOPED A NON-OPEN RED AREA WITH BURNING LOCATED UNDER THE DURAHESIVE WAFER FROM STOMA TO APPROXIMATELY THREE EIGHTS (3/8) INCHES AWAY ENCIRCLING STOMA, WHICH OCCURRED APPROXIMATELY THREE (3) WEEKS AGO. THE PATIENT SAW THE ONCOLOGIST WHO ORDERED NYSTATIN POWDER AND DIFLUCONIZOL ORALLY. IT WAS REPORTED THAT PATIENT STARTED USING PRODUCT IN (B)(6) 203 STARTED USING AND DEVELOPED RASH ABOUT THREE (3) WEEKS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311763 SUR-FIT NATURA 2PC DH CONVEX MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC INC. 404594 4A03272

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention