BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINE DRAINAGE BAG

    MDR report key: 28864 · Received November 29, 1995

    Report

    Report Number
    1483039-1995-00026
    Event Type
    Malfunction
    Date Received
    November 29, 1995
    Report Date
    November 27, 1995
    Manufacturer
    PLASCO, INC.
    Product Code
    EYZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PER HEALTHCARE PROFESSIONAL, BAGS ARE NOT DRAINING AND URINE IS BACKING UP INTO TUBING. NO CUSTOMER INJURY OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URINE DRAINAGE BAG URINE DRAINAGE BAG EYZ PLASCO, INC. 6852-415

    Patients

    Seq Age Sex Outcome Treatment
    1 *