BEUDAMED
    FDA Adverse Event Death Summary report: N

    A-18

    MDR report key: 437073 · Received January 7, 2003

    Report

    Report Number
    1423500-2002-01671
    Event Type
    Death
    Date Received
    January 7, 2003
    Date of Event
    September 1, 2001
    Report Date
    December 11, 2002
    Manufacturer
    ATHIN MEDICAL, AN AFFILIATE OF BHC
    Product Code
    FJI
    Removal / Correction Number
    1423500-10/16/01-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VIA THIRD PARTY LAWSUIT, PATIENT'S SUCCESSOR REPORTED PATIENT DIED AS A RESULT OF A PULMONARY EMBOLISM. THE PATIENT WAS USING THE CT 110 AND A-18 DIALYZERS. NO ADDITONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 A-18 HOLLOW FIBER DIALYZER FJI ATHIN MEDICAL, AN AFFILIATE OF BHC A-18 NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death