BEUDAMED
    FDA Adverse Event Other Summary report: N

    KIT, CABG PART 2, ST JOSEPH

    MDR report key: 695000 · Received March 30, 2006

    Report

    Report Number
    1423507-2006-00037
    Event Type
    Other
    Date Received
    March 30, 2006
    Date of Event
    March 2, 2006
    Report Date
    March 28, 2006
    Manufacturer
    CARDINAL HEALTH
    Product Code
    NAV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    O.R STAFF NOTICED A MUSTY ORDOR APPROXIMATELY 20 MINUTES AFTER OPENING PART TWO OF THE CUSTOM STERILE PACK. SEVERAL STAFF MEMBERS BECAME ILL ENOUGH TO HAVE TO LEAVE THE ROOM AND REPORT TOTHE EMPLOYEE HEALTH CLINIC FOR EVALUATION. TREATMENT IS NOT KNOWN AT THIS TIME. THE SURGEON FELT ILL AND ASKED TO BE RELIEVED BY ANOTHER SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT, CABG PART 2, ST JOSEPH KIT, CABG PART 2, ST JOSEPH NAV CARDINAL HEALTH PCVNCGBSJW 10001422

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other