BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4132812 · Received September 29, 2014

    Report

    Report Number
    1049092-2014-11329
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    November 24, 2012
    Report Date
    January 24, 2013
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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.

    Description of Event or Problem · 1

    PER THE END USER, RASH UNDER TAPE BORDER. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606494 S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) CONVEX WAFER PROTECTOR, OSTOMY EXE CONVATEC INC. 413180 2K00489

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other