BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SFS/SUR-FIT 2PC-2PC STOMAHESIVE (SH)

    MDR report key: 4020740 · Received July 30, 2014

    Report

    Report Number
    1049092-2014-10208
    Event Type
    Injury
    Date Received
    July 30, 2014
    Date of Event
    August 9, 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
    PA, 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 3 DIFFERENT PRODUCT APPLICATIONS. THE REPORT STATES THAT THERE ARE NO SIGNIFICANT TRENDS.

    Description of Event or Problem · 1

    END-USER REPORTED SIGNS OF INFLAMMATION/RASH UNDER PRODUCT. IT WAS NOTED THAT END-USER HAS BEEN USING PRODUCT FOR (14) YEARS AND RECENTLY DEVELOPED RASH UNDER TAPE COLLAR DEMARKATED LINES AND IMPRINT OF WAFER. PT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445719 SFS/SUR-FIT 2PC-2PC STOMAHESIVE (SH) PROTECTOR, OSTOMY EXE CONVATEC, INC 125259 8L34907

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention