BEUDAMED
    FDA Adverse Event Summary report: N

    HEMODIALYZER

    MDR report key: 22623 · Received June 8, 1995

    Report

    Report Number
    2243621-1995-05114
    Date Received
    June 8, 1995
    Date of Event
    April 12, 1995
    Report Date
    June 6, 1995
    Manufacturer
    CGH MEDICAL
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    FACILITY ALLEGES BLOOD LEAK DURING TREATMENT. RN REPORTS LEAK OCCURRED ON 22ND USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMODIALYZER HEMODIALYZER FJI CGH MEDICAL BIO ALLERGIC 93518

    Patients

    Seq Age Sex Outcome Treatment
    1 *