BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4101170 · Received September 17, 2014

    Report

    Report Number
    1049092-2014-11469
    Event Type
    Injury
    Date Received
    September 17, 2014
    Report Date
    March 21, 2013
    Manufacturer
    CONVATEC, INC
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 INFO 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.

    Description of Event or Problem · 1

    REPORT PROVIDED BY THE END USER STATES THAT THEY HAVE EXPERIENCED A RED ITCHY RASH UNDER THE TAPE BORDER ONLY. THE END USER HAS TRIED POWDER AND CUTTING THE TAPE OFF, BUT THE APPLIANCE WILL NOT STICK AFTER THAT. THE END USERS SUBSEQUENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574093 S4S/SUR-FIT NATURA 2PC-2PC DURAHESIVE (DH) MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC, INC 411804 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention