BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S4S/SUR-FIT NATURA 2 PC - 2 PC STOMAHESIVE (SH) MOLDABLE WAFER

    MDR report key: 4101564 · Received August 19, 2014

    Report

    Report Number
    1049092-2014-10585
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    April 3, 2012
    Report Date
    April 3, 2012
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K800750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 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 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 REC'D INDICATED THE PATIENT DEVELOPED A RED, ITCHY, UNIFORM RASH UNDER THE TAPE COLLAR WITHIN 2 HOURS OF TRYING THE PRODUCT. NO FURTHER INFO WAS PROVIDED AND THE PATIENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500275 S4S/SUR-FIT NATURA 2 PC - 2 PC STOMAHESIVE (SH) MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC INC. 411805 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention