BEUDAMED
    FDA Adverse Event Summary report: N

    MONOFLO DRAINAGE BAG

    MDR report key: 734299 · Received June 5, 2006

    Report

    Report Number
    734299
    Date Received
    June 5, 2006
    Date of Event
    December 9, 2006
    Manufacturer
    KENDALL
    Product Code
    EYZ
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLEY URINE BAG NOT EMPTIED ON PATIENT; FOUND BULGING BY PHYSICIAN ON ROUNDS. CONCERN ABOUT POSSIBLE OBSTRUCTION OF FLOW. PATIENT CARDIAC CATHETERIZATION PROCEDURE PUT ON HOLD. 3100 ML EMPTIED. NO PERMANENT INJURY NOTED IN FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOFLO DRAINAGE BAG BAG, FOLEY EYZ KENDALL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * CARDIAC DRUGS