BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3986358 · Received July 25, 2014

    Report

    Report Number
    1049092-2014-10203
    Event Type
    Injury
    Date Received
    July 25, 2014
    Report Date
    September 2, 2011
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 (B)(4) ISSUED APRIL 16, 2014. DEVICE(S) LISTEN IN THIS REPORT IS (ARE) USED FOR TREATMENT, NO DIAGNOSIS. ANY ADD'L INFO REC'D 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 (B)(4) 2011. THE DATA PRESENTED IS FROM THREE DIFFERENT PRODUCT APPLICATIONS. THIS REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS.

    Description of Event or Problem · 1

    REPORT REC'D INDICATED THAT PATIENT HAD SIGNS OF RED BUMPS AND GENERALIZED IRRITATED SKIN UNDER WAGER AND RASH/ITCH UNDER MASS/BORDER, EXCEPT DIRECTLY AROUND STOMA WHERE 2 INCH EAKIN WAS. AREA IS INTERMITTENTLY ITCHY WITH PATCHY AREAS OF CLUSTERED WHITE BUMPS. GENERALIZED IRRITATION IS IN SHAPE OF DURAHESIVE WAFER. REPORT NOTED THAT NYSTATIN POWDER WAS USED, HOWEVER PATIENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437003 S4S/SUR-FIR NATURA 2 PC - 2 PC DURAHESIVE (DH) PROTECTOR, OSTOMY EXE CONVATEC, INC. 413155 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention