BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4122194 · Received September 17, 2014

    Report

    Report Number
    1049092-2014-10263
    Event Type
    Injury
    Date Received
    September 17, 2014
    Report Date
    October 12, 2011
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K830945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    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 INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. 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. THE BRAND NAME SHOULD READ AS S4S/SUR-FIT NATURA 2PC-2PC DURAHESIVE (DH) FLEXIBLE WAFER.

    Description of Event or Problem · 1

    REPORT PROVIDED BY THE END USER STATES THAT THEY HAVE EXPERIENCED RED, ITCHY SKIN NEAR THE OUTER EDGES ALL AROUND THE APPLIANCE. THE RASH IS NOT SOLID, BUT IN PATCHES NEAR OUTER EDGES. THE END USER ALSO HAS SMALL TENDER REDDENED AREA ABOUT A QUARTER INCH FROM BASE OF STOMA. THE END USER IS USING A BARRIER WIPE. NO LOT NUMBER AVAILABLE FOR WAFER OR BARRIER WIPE. THE END USER SOUGHT MEDICAL ADVISE AND WILL TRY AN OSTOMY POWDER WITH BARRIER WIPES. THE END USER WAS ALSO ADVISED TO SEE A HOME HEALTHCARE PROVIDER TO DETERMINE IF THE RASH IS DUE TO A FUNGAL ISSUE. THE END USERS SUBSEQUENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575747 S4S/SUR-FIT NATURA 2PC-2PC DURAHESIVE (DH) PROTECTOR, OSTOMY EXE CONVATEC INC. 413166

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention