BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SFS/SUR-GIT NATURA 2PC-2PC DURAHESIVE (DH)

    MDR report key: 4020758 · Received July 30, 2014

    Report

    Report Number
    1049092-2014-10207
    Event Type
    Injury
    Date Received
    July 30, 2014
    Date of Event
    August 30, 2011
    Report Date
    September 6, 2011
    Manufacturer
    CONVATEC INC
    Product Code
    EXE
    PMA / PMN Number
    K855018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    REPORT RECEIVED INDICATED THAT THE CUSTOMER REPORTED REDNESS, A RASH AND ITCHING IMMEDIATELY AROUND STOMA BASE ONLY. PT OUTCOME WAS REPORTED AS AFTER USING POWDER AND VARIOUS PRODUCTS, PT EXPERIENCED SOME IMPROVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445897 SFS/SUR-GIT NATURA 2PC-2PC DURAHESIVE (DH) PROTECTOR, OSTOMY EXE CONVATEC INC 404593 1E010398

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention