BEUDAMED
    FDA Adverse Event Other Summary report: N

    F-DRAINBAG, LATEX FREE, 2000M

    MDR report key: 536164 · Received July 26, 2004

    Report

    Report Number
    1417592-2004-00020
    Event Type
    Other
    Date Received
    July 26, 2004
    Date of Event
    June 30, 2004
    Report Date
    July 21, 2004
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    EYZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, TWO PTS CONTRACTED URINARY TRACT INFECTIONS WHILE UTILIZING THE DRAIN BAGS. THE PTS WERE TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F-DRAINBAG, LATEX FREE, 2000M DRAINAGE BAG EYZ MEDLINE INDUSTRIES, INC. DYND15205H 031504A

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention