BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S4S/SUR-FIT NATURA 2PC-2PC DURAHESIVE (DH) CONVEX MOLDABLE WAFER

    MDR report key: 4101160 · Received September 17, 2014

    Report

    Report Number
    1049092-2014-11467
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    March 18, 2013
    Report Date
    March 20, 2013
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ANALYSIS IS TAKEN FROM A TRENDING REPORT OF EVAL OR ADVERSE EVENTS FINALIZED (B)(6) 2011. THE DATA PRESENTED IS FROM THREE DIFFERENT PRODUCT APPLICATIONS. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS.

    Description of Event or Problem · 1

    REPORT PROVIDED BY THE WOUND OSTOMY CONTINENCE NURSE STATES THAT THE END USER EXPERIENCED A RED, ITCHY, UNIFORM RASH, CONSISTENT WITH ALLERGY, UNDER TAPE COLLAR. STATES HAS NUMEROUS TAPE SENSITIVITIES. CLEANSES WITH WATER THEN DRIES THEN APPLIES A SKIN BARRIER TO SKIN, DRIES, AND THEN WAFER. THE WOUND OSTOMY CONTINENCE NURSE WILL PATCH TEST AND USE AN OSTOMY BARRIER SPRAY OR AN ALTERNATE BARRIER UNDER THE TAPE. THE END USERS SUBSEQUENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576822 S4S/SUR-FIT NATURA 2PC-2PC DURAHESIVE (DH) CONVEX MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC, INC. 404593 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention