BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4100866 · Received September 12, 2014

    Report

    Report Number
    1049092-2014-11613
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    April 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    CONVATEC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 FORM 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 PT DEVELOPED FIERY REDNESS WITH WEEPING OVER ABOUT 60 PERCENT OF THE AREA BENEATH THE MASS A MONTH AGO. THE PT HAS BEEN SEEN BY THE ET NURSE, A DERMATOLOGIST, AND NONE OF THE TREATMENTS IMPROVED THE CONDITION. NO FURTHER INFORMATION WAS PROVIDED AND THE PT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566202 S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) CONVEX MOLDABLE WAFER PROTECTOR, OSTOMY EXE CONVATEC. 404593 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention