BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAINAGE BAG WITH REFLUX VALVE

    MDR report key: 444679 · Received February 25, 2003

    Report

    Report Number
    1417592-2003-00007
    Event Type
    Injury
    Date Received
    February 25, 2003
    Date of Event
    January 29, 2003
    Report Date
    February 19, 2003
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    EYZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY PTS CONTRACTED URINARY TRACT INFECTIONS WHILE UTILIZING THE DRAINBAGS. THE PTS WERE TREATED WITH ANTIBIOTICS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention