BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONO-FLO

    MDR report key: 679908 · Received February 9, 2006

    Report

    Report Number
    679908
    Event Type
    Malfunction
    Date Received
    February 9, 2006
    Date of Event
    January 24, 2006
    Report Date
    February 9, 2006
    Manufacturer
    KENDALL, A DIVISION OF TYCO HEALTHCARE GROUP
    Product Code
    EYZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE FOLEY DRAINAGE SYSTEM WITH THE UROMETER ON THE BAG HAS A LOOSE FITTING WHERE THE CLEAR TUBING JOINS THE WHITE CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONO-FLO DRAINAGE BAG EYZ KENDALL, A DIVISION OF TYCO HEALTHCARE GROUP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *