BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIANS TERUMO DIALYZER

    MDR report key: 110630 · Received July 14, 1997

    Report

    Report Number
    110630
    Event Type
    Injury
    Date Received
    July 14, 1997
    Date of Event
    April 28, 1997
    Report Date
    June 16, 1997
    Manufacturer
    NATIONAL MEDICAL CARE
    Product Code
    FJI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 4/28/97 PT WAS BEING GIVEN A DIALYSIS TREATMENT AND WITHIN THE FIRST 2 MINUTES PT COMPLAINED OF SHORTNESS OF BREATH AND LOWER BACK PAIN. TREATMENT WAS STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARIANS TERUMO DIALYZER DIALYZER FJI NATIONAL MEDICAL CARE C-121 8896G09

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention