BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAY, FOLEY, URINE METER, BARDEX I.C. COMPLETE CARE, INFECTI

    MDR report key: 2181431 · Received July 15, 2011

    Report

    Report Number
    2181431
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 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 WAS LEAKING. IT APPEARED TO HAVE A HOLE NEAR THE TOP OF THE BAG. SEE PREVIOUS EVENT REPORTS. ALTHOUGH THIS IS A NON TEMP-SENSING CATHETER, IT IS FROM SAME LINE OF PRODUCT AT BARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAY, FOLEY, URINE METER, BARDEX I.C. COMPLETE CARE, INFECTI FOLEY CATHETER W BAG ATTACHED KOD BARD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR NONE APPLICABLE