BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4096333 · Received September 2, 2014

    Report

    Report Number
    1049092-2014-11398
    Event Type
    Injury
    Date Received
    September 2, 2014
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 (B)(4) 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 PROVIDED BY THE END USER STATES THAT THEY HAVE DEVELOPED REDNESS UNDER THE CENTER OF THE PRODUCT AFTER STARTING CHEMOTHERAPY. THE PATIENTS SUBSEQUENT OUTCOME WAS NOT NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532136 S4S/SUR-FIT NATURA 2PC-2PC DURAHESIVE (DH) CONVEX MOLDABLE WAFER. PROTECTOR, OSTOMY EXE CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C. 404593

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention