BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTOFLO II URINARY DRAINAGE BAG

    MDR report key: 57606 · Received December 23, 1996

    Report

    Report Number
    MW1010450
    Event Type
    Malfunction
    Date Received
    December 23, 1996
    Date of Event
    October 20, 1996
    Report Date
    December 20, 1996
    Manufacturer
    BAXTER HEALTHCARE CORP. RENAL DIV.
    Product Code
    EYZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT REPORTS LAST 3 URINARY BAGS LEAK NEAR CLAMP LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYSTOFLO II URINARY DRAINAGE BAG URINARY DRAINAGE BAG EYZ BAXTER HEALTHCARE CORP. RENAL DIV. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR