BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4132837 · Received September 29, 2014

    Report

    Report Number
    1049092-2014-11753
    Event Type
    Injury
    Date Received
    September 29, 2014
    Report Date
    June 18, 2013
    Manufacturer
    CONVATEC INC.
    Product Code
    EXE
    PMA / PMN Number
    K833625
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 (B)(4) DIFFERENT PRODUCT APPLICATIONS. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS.

    Description of Event or Problem · 1

    PATIENT REPORTED SHE DEVELOPED A SKIN IRRITATION TO RIGHT OF THE STOMA TO ONE EIGHTH OF AN INCH AREA. PATIENT CLEANED AREA WITH A SAFE AND SIMPLE COMPETITIVE ADHESIVE REMOVER, AND A GEL PREP, ALONG WITH AN ADHESIVE POWDER TO THE SITE. THE END USER SUBSEQUENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606255 S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) PROTECTOR OSTOMY EXE CONVATEC INC. 413166 3C00177

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other