BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRAN PLUS

    MDR report key: 37345 · Received September 6, 1996

    Report

    Report Number
    1718873-1996-00003
    Event Type
    Death
    Date Received
    September 6, 1996
    Date of Event
    August 1, 1996
    Manufacturer
    UTAH MED PRODUCTS, INC.
    Product Code
    KXO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS BY UTAH MEDICAL PRODUCTS, INC., TO OBTAIN ADDITIONAL INFO AND/OR ARRANGE ON-SITE PRODUCT EVALUATION HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    PT WAS 40+ WEEKS IN ACTIVE LABOR. UPON INSERTION OF INTRAN PLUS, 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 CATHETER KXO UTAH MED PRODUCTS, INC. IUP-400 61645-1

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death| O