BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT190G

    MDR report key: 36383 · Received August 27, 1996

    Report

    Report Number
    1423500-1996-00001
    Event Type
    Injury
    Date Received
    August 27, 1996
    Date of Event
    August 3, 1996
    Report Date
    August 22, 1996
    Manufacturer
    NISSHO CORP
    Product Code
    FJI
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PT HAD A REACTION DURING TREATMENT. PT COMPLAINED OF CHEST PAIN AND SHORTNESS OF BREATH DURING TRIAL USE OF DIALYZER. PT WAS GIVEN NORMAL SALINE, TWO SUBLINGUAL NITROGLYCERIN AND TREATMENT WAS TERMINATED. PT WAS TRANSFERRED TO ICCU WITH DIAGNOSIS OF DIALYSIS INDUCED ANGINA WITHOUT MYOCARDIAL INFARCTION. PT WAS DISCHARGED ON 8/6/96 FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT190G CELLULOSE TRIACETATE DIALYZER FJI NISSHO CORP CT 190G A94J17X

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening