BEUDAMED
    FDA Adverse Event Other Summary report: N

    URINARY DRAINAGE BAG

    MDR report key: 28546 · Received November 10, 1995

    Report

    Report Number
    1483039-1995-00017
    Event Type
    Other
    Date Received
    November 10, 1995
    Date of Event
    October 22, 1995
    Report Date
    November 9, 1995
    Manufacturer
    PLASCO, INC.
    Product Code
    FCN
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HEALTH CARE PROFESSIONAL REPORTED THAT PT DEVELOPED A URINARY TRACT INFECTION AS A RESULT OF URINE BACKING-UP INTO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URINARY DRAINAGE BAG URINARY DRAINAGE BAG FCN PLASCO, INC. 6633-345

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other