BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRANPLUS IUP-C50

    MDR report key: 1195163 · Received October 9, 2008

    Report

    Report Number
    1195163
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    September 19, 2008
    Report Date
    October 8, 2008
    Manufacturer
    UTAH MEDICAL PRODUCTS
    Product Code
    KXO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS (B)(6) PT WAS DISCHARGED POST C-SECTION ON (B)(6) 2008. ON (B)(6)2008, THE PT HAD A PIECE OF PLASTIC COME OUT OF HER VAGINA. IT IS THE PIECE OF PLASTIC AROUND THE TIP OF THE IUPC. PER THE MD, THERE IS NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRANPLUS IUP-C50 IUPC KXO UTAH MEDICAL PRODUCTS 1080817

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR