BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4122247 · Received September 17, 2014

    Report

    Report Number
    1049092-2014-10995
    Event Type
    Injury
    Date Received
    September 17, 2014
    Report Date
    October 9, 2012
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. DEVICE NAME: UNK. S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) MOLDABLE WAFER. ANALYSIS IS TAKEN FROM A TRENDING REPORT OF EVALUATION 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

    IT WAS REPORTED THAT REDNESS AND ITCHING WAS NOTED TO THE SKIN AT THE DISTAL END OF THE HYDROCOLLOID TAPE COLLAR OF THIS SKIN BARRIER. THE PT FIRST NOTED THIS AREA APPROXIMATELY 1 MONTH BEFORE REPORTING THIS EVENT. HE SAID THE REDNESS COMES AND GOES. NO ADDITIONAL INFO WAS PROVIDED. PT OUTCOME IS REPORTED AS THE PT REPOSITIONS THE SKIN BARRIER TO AVOID THE REDDENED AREA AND THE REDNESS AND ITCHING RESOLVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575707 S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) PROTECTOR/OSTOMY EXE CONVATEC, INC. 411802

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention