BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4203040 · Received September 17, 2014

    Report

    Report Number
    1049092-2014-11496
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    April 1, 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 ADD'L 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 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 RECEIVED INDICATED THE PT DEVELOPED ONE OPEN AREA UNDER MASS TO RIGHT LOWER AREA 1/2" BY 3/8" IN SIZE. THE REPORTED NOTED THAT THE AREA BECAME PINK AND WEEPY WITH DRAINAGE. AS A RESULT, THE PT WAS PRESCRIBED A ANTIBIOTIC BY A PHYSICIAN. PT OUTCOME WAS NOT NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575323 S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) CONVEX WAFER PROTECTOR, OSTOMY EXE CONVATEC, INC. 413181

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention