BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4053559 · Received August 27, 2014

    Report

    Report Number
    1049092-2014-10224
    Event Type
    Injury
    Date Received
    August 27, 2014
    Report Date
    September 16, 2011
    Manufacturer
    CONVATEC, INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 04/16/2014. 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. H3. 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

    REPORTED RECEIVED STATES THAT PATIENT DEVELOPED ULCERS AND BLISTER/BREAKDOWN AT 3 AND 9 O'CLOCK UNDER BORDER/MASS PORTION OF WAFER. PATIENT HAS HAD ULCER FOR A COUPLE OF MONTHS. PATIENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522489 S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) CONVEX MOLDABLE WAFER EXE CONVATEC, INC. 413184 1D01143

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention