BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA MOLDABLE STOMAHESIVE SKIN BARRIER

    MDR report key: 4810463 · Received June 1, 2015

    Report

    Report Number
    1049092-2015-00289
    Event Type
    Injury
    Date Received
    June 1, 2015
    Report Date
    May 18, 2015
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH BATCH (B)(4). WAS MADE ACCORDING TO SPECIFICATION. AFTER DETAILED BATCH REVIEW, NO DISCREPANCIES (INCLUDES NON-CONFORMANCES/DEVIATIONS) WERE FOUND. THERE IS NOT ENOUGH INFORMATION TO CONCLUDE THE PRODUCT DID NOT MEET SPECIFICATION AND PERFORM AS INTENDED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. PREVIOUS INVESTIGATION, IS APPLICABLE TO THIS COMPLAINT INVESTIGATION. THIS PREVIOUS INVESTIGATION IS OPEN. THEREFORE, THIS COMPLAINT WILL REMAIN OPEN UNTIL COMPLETION OF THE PREVIOUS INVESTIGATION. ON DECEMBER 30, 2015 IT WAS NOTED THAT PREVIOUS NC IS APPLICABLE TO THIS COMPLAINT AND IS CLOSED. NO FURTHER ACTIONS ARE REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. 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 JANUARY 12, 2016. (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. MANUFACTURER REPORT NUMBER: 1049092-2015-00289. HEIGHT: (B)(6).

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: INVESTIGATION RESULTS WERE OMITTED FROM MDR MFR # 1049092-2015-00289 SUBMITTED ON JANUARY 12, 2016. INVESTIGATION RESULTS WERE RECEIVED ON DECEMBER 30, 2015 AND ARE AS FOLLOWS: THE COMPLAINT/INCIDENCE DATA-POST MARKET DATA ANALYSIS (TREND ANALYSIS), CLINICAL REVIEW, ROOT CAUSE ANALYSIS AND RISK ASSESSMENT INDICATE A CONSISTENT RATE OF COMPLAINTS BY THE END USER AS A RESULT OF SKIN COMPLICATIONS 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. 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 REPORTS INTERMITTENT PERISTOMAL REDNESS UNDER OF THE MASS FOR THE PAST 15 YEARS. HE PRESENTED TO THE DERMATOLOGIST WHO PRESCRIBED TOPICORT SPRAY TO THE PERISTOMAL SKIN. HE ADVISED SYMPTOMS HAVE RESOLVED AND HIS SKIN IS CLEAR AND INTACT PRESENTLY. END USER WAS INSTRUCTED ON USE OF ADHESIVE REMOVER, USING A SOAP WITH NO OILS; CREAMS OR MOISTURIZERS; POWDER; AND BARRIER WIPE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353517 NATURA MOLDABLE STOMAHESIVE SKIN BARRIER PROTECTOR, OSTOMY EXE CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. 411803 4L00491

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention