BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRAN PLUS

    MDR report key: 35796 · Received August 2, 1996

    Report

    Report Number
    35796
    Event Type
    Death
    Date Received
    August 2, 1996
    Date of Event
    August 1, 1996
    Report Date
    August 1, 1996
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    KXO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT 40+ WEEKS IN ACTIVE LABOR. UPON INSERTION OF DEVICE, THERE WAS A DECREASE IN B/P INTO THE 50'S. THERE WAS A LARGE AMOUNT OF VAGINAL BLEEDING. AN EMERGENCY C-SECTION WAS PERFORMED WITH FETAL DEMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAN PLUS DISPOSABLE INTRAUTERINE PRESSURE KXO UTAH MEDICAL PRODUCTS, INC. IUP-400 61645-1

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death| O