BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARING DRAIN BAG

    MDR report key: 462963 · Received May 30, 2003

    Report

    Report Number
    1417592-2003-00021
    Event Type
    Other
    Date Received
    May 30, 2003
    Date of Event
    May 10, 2003
    Report Date
    May 20, 2003
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    EYZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY FOUR PATIENTS CONTACTED URINARY TRACT INFECTIONS WHILE UTILIZING THE DRAIN BAGS. THE PATIENTS WERE TREATED WITH ANTIBIOTICS AND NO FURTHER MEDICAL TREATMENT WAS REQUIRED.

    Description of Event or Problem · 2

    REPORTEDLY FOUR PATIENTS CONTRACTED URINARY TRACT INFECTIONS WHILE UTILIZING THE DRAIN BAGS. THE PATIENTS WERE TREATED WITH ANTIBIOTIC AND NO FURTHER MEDICAL TREATMENT WAS REQUIRED.

    Description of Event or Problem · 3

    REPORTEDLY FOUR PATIENTS CONTRACTED URIANRY TRACT INFECTIONS WHILE UTILIZING THE DRAIN BAGS. THE PATIENTS WERE TREATED WITH ANTIBOTICS AND NO FURTHER MEDICAL TREATMENT WAS REQUIRED.

    Description of Event or Problem · 4

    REPORTEDLY FOUR PATIENTS CONTRACTED URINARY TRACT INFECTIONS WHILE UTILIZING THE DRAIN BAGS. THE PATIENTS WERE TREATED WITH ANTIBIOTICS AND NO FURTHER MEDICAL TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARING DRAIN BAG DRAINAGE BAG EYZ MEDLINE INDUSTRIES, INC. DYNC1674 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention
    2 * Required Intervention
    3 * Required Intervention
    4 *