BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA DURAHESIVE SKIN BARRIER W/FLANGE (OVE

    MDR report key: 4683612 · Received April 10, 2015

    Report

    Report Number
    1049092-2015-00204
    Event Type
    Injury
    Date Received
    April 10, 2015
    Date of Event
    February 2, 2015
    Report Date
    April 1, 2015
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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. (B)(6).

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH BATCH 4J02652 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. 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

    ADDITIONAL INFORMATION: PREVIOUS APPLICABLE NC INVESTIGATION HAS BEEN COMPLETED. THE INVESTIGATION REVEALED THAT 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 REPORTED THAT HE DEVELOPED AN ULCERATION DESCRIBED AS RED AND WITH MINIMAL DEPTH UNDER HIS WAFER. HIS SIZE IS APPROXIMATELY ONE HALF (0.5) INCH BY ONE QUARTER (0.25) OF AN INCH AND IS APPROXIMATELY ONE EIGHTH TO ONE FOURTH OF AN INCH AWAY FROM THE STOMA. DRAINAGE WAS REPORTED BUT THE TYPE AND AMOUNT WERE NOT PROVIDED. THE PATIENT SOUGHT TREATMENT FROM HIS COLORECTAL SURGEON AND WAS PRESCRIBED A SALVE (NAME NOT PROVIDED), WHICH HE HAS NOT YET OBTAINED FROM THE PHARMACY. FOUR DAYS LATER, THE PATIENT SOUGHT FURTHER TREATMENT FROM A NURSE PRACTITIONER, WHO RECOMMENDED TREATMENT WITH ABSORBENT WOUND DRESSING PRODUCT AND AN WAFER SEAL. THE PATIENT FURTHER INDICATED A BIOPSY MAY BE PERFORMED IN ORDER TO MAKE AN APPROPRIATE DIAGNOSIS. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243107 NATURA DURAHESIVE SKIN BARRIER W/FLANGE (OVE PROTECTOR, OSTOMY EXE CONVATEC INC. 413155 4J02652

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention RANEXA| CRESTOR| XARELTO| ASPIRIN (LOW DOSE)