BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUR-FIT NATURA DURAHESIVE SKIN BARRIER W/CONVEX-IT W/45MM (1 3/4") FLANGE W/WHIT

    MDR report key: 4100888 · Received September 12, 2014

    Report

    Report Number
    1049092-2014-11093
    Event Type
    Injury
    Date Received
    September 12, 2014
    Report Date
    November 19, 2012
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.
    Product Code
    EXE
    PMA / PMN Number
    K830945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS IS TAKEN FROM A TRENDING REPORT OF EVALUATIONS OR ADVERSE EVENTS FINALIZED MAY 2011. THE DATA PRESENTED IS FROM THREE DIFFERENT PRODUCT APPLICATIONS. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS. CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO THE FDA 483 ISSUED APRIL 16, 2014. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE ON A SUPPLEMENTAL MDR. SUR-FIT NATURA DURAHESIVE SKIN BARRIER W/CONVEX-IT W/45MM (1 3/4") FLANGE W/WHITE TAPE COLLAR AND PRE-CUT OPENING.

    Description of Event or Problem · 1

    THE PATIENT REPORTED SHE DEVELOPED A REDDENED AREA AROUND THE ENTIRE STOMA UNDER THE WAFER. THE PATIENT INDICATED THE AREA OCCASIONALLY EXUDES SCANT SEROSANGUINOUS DRAINAGE. THE DISCOLORATION HAS PERSISTED FOR APPROXIMATELY TWO MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565797 SUR-FIT NATURA DURAHESIVE SKIN BARRIER W/CONVEX-IT W/45MM (1 3/4") FLANGE W/WHIT PROTECTOR, OSTOMY EXE CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. 413180

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention