BEUDAMED
    FDA Adverse Event Death Summary report: N

    A-18

    MDR report key: 352836 · Received September 20, 2001

    Report

    Report Number
    1423500-2001-01364
    Event Type
    Death
    Date Received
    September 20, 2001
    Date of Event
    September 1, 2001
    Report Date
    September 2, 2001
    Manufacturer
    ALTHIN MEDICAL, AN AFFILIATE OF HBC
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INTERNATIONAL COMPLAINT COORDINATOR REPORTS ONE INCIDENT OF PT DEATH AFTER USING THE A-18 DIALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43043 A-18 HOLLOW FIBER DIALYZER FJI ALTHIN MEDICAL, AN AFFILIATE OF HBC A-18 NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death