BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4100865 · Received September 12, 2014

    Report

    Report Number
    1049092-2014-11036
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    K830945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS IS TAKEN FORM 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 FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAS DEVELOPED SKIN IRRITATION UNDER THE TAPE COLLAR OF THE DEVICE. THE ISSUE WAS PERSISTED FOR APPROXIMATELY 2 YEARS. THE PT WAS ADVISED BY HER WOUND AND OSTOMY CARE NURSE TO DISCONTINUE USING THE DEVICE AND OPT FOR A DIFFERENT BRAND/MODEL OF DEVICE. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566090 SUR-FIT NATURA DURAHESIVE SKIN BARRIER W/CONVEX-IT W/45MM(1 3/4")FLANGE W/WHITE PROTECTOR, OSTOMY EXE CONVATEC, INC. 413181 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention