BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRAIN BAG WITH REFLUX VALVE

    MDR report key: 455832 · Received April 22, 2003

    Report

    Report Number
    1417592-2003-00012
    Event Type
    Other
    Date Received
    April 22, 2003
    Date of Event
    September 18, 2002
    Report Date
    April 8, 2003
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    EYZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    URINE IN A DRAINAGE BAG BACKED UP, WHICH COULD POTENTIALLY LEAD TO A URINARY TRACT INFECTION. THERE WAS NO ADVERSE EFFECT ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAIN BAG WITH REFLUX VALVE URINE COLLECTOR EYZ MEDLINE INDUSTRIES, INC. DYNC1674 042802A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention