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: 4100712 · Received September 12, 2014

    Report

    Report Number
    1049092-2014-11608
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    February 1, 2013
    Report Date
    May 7, 2013
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    K830945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 INFORMATION RECEIVED 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 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 PATIENT HAD AN INTERMITTENT RED RASH UNDER THE MASS EXTENDING OUT A QUARTER OF AN INCH FROM THE STOMA IN A CIRCULAR PATTERN SINCE (B)(6) 2013. NO FURTHER INFORMATION WAS PROVIDED AND THE PATIENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565142 S4S/SUR-FIT NATURA 2 PC - 2 PC STOMAHESIVE (SH) WAFER W/ FLEXIBLE COLLAR PROTECTOR, OSTOMY EXE CONVATEC, INC. 125259 2L00066

    Patients

    Seq Age Sex Outcome Treatment
    1 Other