BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALYZER

    MDR report key: 14685 · Received July 14, 1994

    Report

    Report Number
    MW1002824
    Event Type
    Malfunction
    Date Received
    July 14, 1994
    Date of Event
    June 14, 1994
    Report Date
    June 29, 1994
    Manufacturer
    ALTHIN MEDICAL, INC.
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BLOOD LEAK ON DIALYZER. (SEE ALSO 1002823.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIALYZER DIALYZER FJI ALTHIN MEDICAL, INC. 160 MCA 160 843940426R

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR