BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZEM

    MDR report key: 375868 · Received February 4, 2002

    Report

    Report Number
    MW1024009
    Event Type
    Malfunction
    Date Received
    February 4, 2002
    Date of Event
    September 13, 2001
    Report Date
    January 31, 2002
    Manufacturer
    E-Z-EM, INC.
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: BREAST BIOPSY WITH NEEDLE GUIDED LOCALIZATION. DURING THE PROCESS OF REMOVING THE GUIDE WIRE THE TIP (OF THE GUIDE WIRE) BROKE OFF, LEAVING THE TIP, EITHER EMBEDDED IN THE TISSUE SAMPLE, OR WITHIN THE PT'S REMAINING TISSUE. INITIAL EVENT NOTED. NO FURTHER EVENTS NOTED FOR FOUR MONTHS. THEN SIX (6) OF TEN (10) CASES INVOLVING THIS PROCEDURE/EQUIPMENT, HAD THE TIP OF THE GUIDE WIRE BREAK OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZEM PERCUGUIDE NEEDLE 20 GA X 3.0 CM FZX E-Z-EM, INC. * M101499-01
    2 EZEM PERCUGUIDE NEEDLE 20 GA X 5.0 CM FZX E-Z-EM, INC * M072499-01

    Patients

    Seq Age Sex Outcome Treatment
    1 *