BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIDUCIAL MARKER

    MDR report key: 7094921 · Received December 7, 2017

    Report

    Report Number
    7094921
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    November 17, 2017
    Report Date
    November 29, 2017
    Manufacturer
    CP MEDICAL, INC.
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE PLACING FIDUCIAL MARKERS IN LIVER, TWO PACKAGES WERE OPENED BOTH WITH SAME LABELING. ONE DEVICE WAS 20CM INSTEAD OF THE LABELED 12CM. FIDUCIAL MARKERS WERE PLACED WITHOUT INCIDENT OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877509 FIDUCIAL MARKER ACCELERATOR, LINEAR, MEDICAL IYE CP MEDICAL, INC. FNS1812-1 160802-80

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR