BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUR-FIT NATURA DURAHESIVE MOLDABLE CONVEX

    MDR report key: 599182 · Received May 2, 2005

    Report

    Report Number
    599182
    Event Type
    Other
    Date Received
    May 2, 2005
    Date of Event
    April 11, 2005
    Report Date
    May 2, 2005
    Manufacturer
    CONVATEC, A BRISTOL-MYERS SQUIBB CO
    Product Code
    EZS
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS IN THE OR FOR VASCULAR PROCEDURE, FEMORAL/FEMORAL BYPASS. THE PATIENT WAS TO BE PREPPED FROM THE NIPPLES TO THE HEELS. THE PATIENT HAD A COLOSTOMY. A STERILE COLOSTOMY BAG WAS REQUESTED. A PACKAGE WAS OPENED BY THE CIRCULATOR NURSE AND PLACED ON THE STERILE FIELD. WHEN THE COLOSTOMY BAGS IN THE STORAGE AREA WAS CHECKED AT THE END OF THE CASE IT WAS DISCOVERED THAT BOTH STERILE AND NON STERILE COLOSTOMY BAGS WERE PRESENT WITH SIMILIAR PACKAGING. STERILE BAGS WERE MARKED STERILE - NON STERILE BAGS WERE NOT MARKED - NONSTERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUR-FIT NATURA DURAHESIVE MOLDABLE CONVEX DRAINABLE POUCH STOMAHESIVE WAFER EZS CONVATEC, A BRISTOL-MYERS SQUIBB CO * *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR