BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX I.C.

    MDR report key: 2150471 · Received June 23, 2011

    Report

    Report Number
    2150471
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BARD
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE FOLEY CATHETER BAG WAS LEAKING. IT WAS LEAKING DOWN NEAR THE DRAIN PORT. AWAITING BOX FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDEX I.C. TEMPERATURE SENSING IC URINE METER FOLEY AND BAG KOD BARD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR NONE---