BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4053558 · Received August 27, 2014

    Report

    Report Number
    1049092-2014-10499
    Event Type
    Injury
    Date Received
    August 27, 2014
    Report Date
    February 22, 2012
    Manufacturer
    CONVATEC, INC.
    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

    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. CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO THE FDA (B)(4) 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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED ITCHING AND REDNESS UNDER ENTIRE DEVICE. THE PATIENT ALLEGEDLY SOUGHT MEDICAL TREATMENT. DETAILS REGARDING THE DIAGNOSIS AND TREATMENT OF THE AFFECTED AREA WERE NOT AVAILABLE. THE PATIENT DISCONTINUED USE OF THE DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522958 S4S/SUR-FIT NATURA 2PC - 2PC DURAHESIVE (DH) CONVEX MOLDABLE WAFER EXE CONVATEC, INC. 411800 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention