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: 4101557 · Received August 19, 2014

    Report

    Report Number
    1049092-2014-10591
    Event Type
    Injury
    Date Received
    August 19, 2014
    Report Date
    April 6, 2012
    Manufacturer
    CONVATEC INC.
    Product Code
    EXB
    PMA / PMN Number
    K830945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 ISSUES 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 HAS HAD A RED RASH ON SKIN UNDER THE TAPE COLLAR FOR THE PAST YEAR. SOME IMPROVEMENT NOTED WHILE ON ANTIBIOTICS. PATIENT CHANGES DEVICE EVERY 2-5 DAYS. NO FURTHER INFORMATION WAS PROVIDED AND THE PATIENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500424 S4S/SUR-FIT NATURA 2 PC - 2 PC STOMAHESIVE (SH) WAFER W/FLEXIBLE COLLAR PROTECTOR, OSTOMY EXB CONVATEC INC. 125277 1H01226

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention