BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4100728 · Received September 12, 2014

    Report

    Report Number
    1049092-2014-11447
    Event Type
    Injury
    Date Received
    September 12, 2014
    Report Date
    March 11, 2013
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. IT IS NOTED THAT THERE ARE BLANK AREAS ON THIS FORM, THE INFORMATION WAS NOT PROVIDED OR IS UNKNOWN. ANALYSIS IS TAKEN FROM A TRENDING REPORT OF EVALUATIONS OR ADVERSE EVENTS FINALIZED (B)(4) 2011. THE DATA PRESENTED IS FROM (B)(4) 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 ITCHING UNDER THE TAPE BORDER ONLY. THE ITCHING OCCURS WITHIN A FEW HOURS OF APPLYING. THE END USER USES PREPARATION WIPES, SOAP AND THEN RINSES. THE END USER SUBSEQUENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565158 S4S/SUR-FIT NATURA 2PC - 2PC DURAHESIVE (DH) MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC, INC. 411800

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention