BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4100857 · Received September 12, 2014

    Report

    Report Number
    1049092-2014-11612
    Event Type
    Injury
    Date Received
    September 12, 2014
    Report Date
    May 8, 2013
    Manufacturer
    CONVATEC INC
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 FORM A TRENDING REPORT OF EVALUATIONS OR ADVERSE EVENTS FINALIZED (B)(4) 2011. THE DATA PRESENTED IS FROM (B)(4) DIFFERENT PRODUCT APPLICATIONS. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THE PT HAD A RED, SCALY RASH UNDER THE TAPE BORDER ONLY. NO FURTHER INFORMATION WAS PROVIDED AND THE PT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566200 S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC INC 411802 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other