BEUDAMED
    FDA Adverse Event Summary report: N

    DIALYZER

    MDR report key: 16470 · Received September 28, 1994

    Report

    Report Number
    MW1003528
    Date Received
    September 28, 1994
    Date of Event
    September 9, 1994
    Report Date
    September 27, 1994
    Manufacturer
    HAEMOTRONIC LTD.
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TWO PTS EXPERIENCED REACTIONS TO FIRST USE OF THIS TYPE OF DIALYZER. ON 9/16/94, PT DEVELOPED BACK PAIN 15 MINUTES INTO TREATMENT WITH A FIRST USE DIALYZER. ON 9/9/94, THE PT ALSO COMPLAINED OF BACK PAIN BUT AT THE TIME THE PT TOLD THE RPTR THAT HE ALSO HAD THE PAIN AT HOME SO THE RPTR DID NOT THINK MUCH OF IT. HIS VITAL SIGNS WERE NORMAL. A FIRST USE DIALYZER WAS BEING USED. THIS PT HAD BEEN USING THIS TYPE OF DIALYZER FOR SEVERAL MONTHS. HE WAS CHANGED TO A CELLULOSE ACETATE DIALYZER AND HAS HAD NO FURTHER PROBLEMS. THE RPTR STATED THAT 85 TO 90% OF THE PTS AT THE FACILITY USE THIS DIALYZER. (ALSO SEE 1003527.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIALYZER DIALYZER FJI HAEMOTRONIC LTD. AM75USD 044A4QJ

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR