BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4012501 · Received August 12, 2014

    Report

    Report Number
    1049092-2014-10666
    Event Type
    Injury
    Date Received
    August 12, 2014
    Date of Event
    April 5, 2012
    Report Date
    May 4, 2012
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 (B)(4) 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. SUS/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) CONVEX MOLDABLE WAFER. 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. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THE PATIENT EXPERIENCED ULCERATED, PINK NON-DRAINING SKIN UNDER THE MASS IN THE 6 O'CLOCK POSITION. THE PATIENT EXPERIENCED THE CONDITION DURING A PERIOD OF ONE MONTH PRIOR TO COMPLAINT RECEIPT. PATIENT HAS USED PRODUCT FOR ONE YEAR. PREPS WILL POWDER AND BARRIER WIPES AND ADDS PASTE AFTER DRYING. PATIENT TREATED WITH ANTIBIOTICS. PATIENT OUTCOME WAS NOT NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478937 S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) PROTECTOR, OSTOMY EXE CONVATEC INC. 404593

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention