BEUDAMED
    FDA Adverse Event Death Summary report: N

    18PIC0D

    MDR report key: 51087 · Received November 23, 1996

    Report

    Report Number
    2022441-1996-00007
    Event Type
    Death
    Date Received
    November 23, 1996
    Date of Event
    August 30, 1996
    Report Date
    September 4, 1996
    Manufacturer
    LUTHER MEDICAL PRODUCTS, INC.
    Product Code
    FOS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UMBILICAL VENOUS CATHETER FOUND TO BE FRACTURED IN THE RIGHT ATRIUM/VENTRICLE BY PATHOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 18PIC0D Implant PLACEMENT SET FOS LUTHER MEDICAL PRODUCTS, INC. * LMP 2904

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DAY Death