BEUDAMED
    FDA Adverse Event Death Summary report: N

    A-18

    MDR report key: 378693 · Received February 22, 2002

    Report

    Report Number
    1423500-2002-00241
    Event Type
    Death
    Date Received
    February 22, 2002
    Date of Event
    December 20, 2000
    Report Date
    January 25, 2002
    Manufacturer
    ALTHIN MEDICAL, AN AFFILIATE OF BHC
    Product Code
    FJI
    Removal / Correction Number
    1423500-10/16/01-002R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    INFO REC'D THROUGH THIRD PARTY NOTIFICATION OF LEGAL CLAIM. PT DIED 10 MINUTES AFTER BEING REMOVED FROM THE DAILYSIS MACHINE. NO FURTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 A-18 HOLLOW FIBER DIALYZER FJI ALTHIN MEDICAL, AN AFFILIATE OF BHC A-18 2000E06R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death