BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S4S/SUR-FIT NATURA 2 PC - 2 PC STOMAHESIVE (SH) WAFER W/ FLEXIBLE COLLAR

    MDR report key: 4122196 · Received September 17, 2014

    Report

    Report Number
    1049092-2014-11497
    Event Type
    Injury
    Date Received
    September 17, 2014
    Report Date
    April 1, 2013
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    K830945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    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. 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

    REPORT RECEIVED INDICATED THE PT DEVELOPED AN ITCHY RASH LOCATED UNDER THE TAPE BORDER. HE ALSO HAS A PINK ULCER 3 MM X 3 MM IN THE 5 O'CLOCK POSITION IN THE PERISTOMAL AREA ABOUT 1 CM OUT FROM STOMA. PRESCRIBED TOPICAL CORTICOSTEROID BY PHYSICIAN. PT OUTCOME WAS NOT NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575560 S4S/SUR-FIT NATURA 2 PC - 2 PC STOMAHESIVE (SH) WAFER W/ FLEXIBLE COLLAR PROTECTOR, OSTOMY EXE CONVATEC, INC. 125266

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention