BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAN PLUS IUP-400

    MDR report key: 1334544 · Received February 25, 2009

    Report

    Report Number
    1334544
    Event Type
    Malfunction
    Date Received
    February 25, 2009
    Date of Event
    February 16, 2009
    Report Date
    February 25, 2009
    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

    PLASTIC SHEATH FOUND ON TIP OF INTRAUTERINE PRESSURE CATHETER SYSTEM (IUPC) PRIOR TO PLACEMENT. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAN PLUS IUP-400 DISPOSABLE INTRAUTERINE PRESSURE CATHETER SYSTEM KXO UTAH MEDICAL PRODUCTS INC. * 1081652

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR