BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA 170G DIALYZER (CELLULOSE ACETATE)

    MDR report key: 160922 · Received April 2, 1998

    Report

    Report Number
    1423500-1998-01202
    Event Type
    Malfunction
    Date Received
    April 2, 1998
    Date of Event
    December 20, 1997
    Report Date
    March 5, 1998
    Manufacturer
    NISSHO
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO REC'D FROM THE CUSTOMER REVEALS A BAXTER DIALYZER WAS NOT USED ON THIS PT. THE CORRECT MFR OF THE DIALYZER WAS NOTIFIED OF THIS EVENT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS PT EXPERIENCED SORE RED EYES. HEALTHCARE PROFESSIONAL REPORTS PT DIAGNOSED WITH INJECTED CONJUNCTIVITIS. THE PT WAS LATER DIAGNOSED WITH EPISCLERITIS, HCP REPORTS THE PT WAS PLACED ON FML. PREDSOL AND SOFRADEX EYE DROPS AS WELL AS SEPTRIM FORTE. HEALTHCARE PROFESSIONAL REPORTS PT RECOVERED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CA 170G DIALYZER (CELLULOSE ACETATE) HOLLOW FIBER DIALYZER FJI NISSHO CA170G A95J30

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening