BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAN PLUS

    MDR report key: 35797 · Received August 2, 1996

    Report

    Report Number
    35797
    Event Type
    Malfunction
    Date Received
    August 2, 1996
    Date of Event
    August 1, 1996
    Report Date
    August 1, 1996
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    KXO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS 40+ WEEKS IN ACTIVE LABOR. DEVICE WAS INSERTED. IT DID NOT FUNCTION PROPERLY AND MONITORING WAS INADEQUATE. IT WAS REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR