BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAN PLUS IUP-400

    MDR report key: 1282083 · Received December 18, 2008

    Report

    Report Number
    1282083
    Event Type
    Malfunction
    Date Received
    December 18, 2008
    Date of Event
    December 2, 2008
    Report Date
    December 18, 2008
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    KXO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    IUPC SENSOR HAS SMALL PLASTIC WRAP AROUND IT THAT COULD POSSIBLY BE LEFT IN PATIENT IF NOT SEEN DURING PLACEMENT. NOT USED ON A PATIENT - NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAN PLUS IUP-400 CATHETER SYSTEM, INTRAUTERINE PRESSURE KXO UTAH MEDICAL PRODUCTS, INC. * 1081451

    Patients

    Seq Age Sex Outcome Treatment
    1 *