BEUDAMED
    FDA Adverse Event Death Summary report: N

    A-18

    MDR report key: 371162 · Received January 4, 2002

    Report

    Report Number
    1423500-2002-00010
    Event Type
    Death
    Date Received
    January 4, 2002
    Date of Event
    August 1, 2001
    Report Date
    December 5, 2001
    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

    BAXTER NOTIFIED OF INCIDENT THROUGH THIRD PARTY LEGAL NOTIFICATION. PATIENT WAS UNDERGOING DIALYSIS AT THE CLINIC. PATIENT UNDERWENT DIALYSIS IN 2001. PATIENT WAS HOSPITALIZED FOLLOWING TREATMENT AND DIED SEVERAL DAYS LATER. 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 NA06

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death