BEUDAMED
    FDA Adverse Event Death Summary report: N

    AF-220

    MDR report key: 378679 · Received February 22, 2002

    Report

    Report Number
    1423500-2002-00242
    Event Type
    Death
    Date Received
    February 22, 2002
    Date of Event
    January 1, 2002
    Report Date
    January 25, 2002
    Manufacturer
    ALTHIN MEDICAL, AN AFFILIATE OF BHC
    Product Code
    KDI
    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 WHILE ON THE DIALYSIS MACHINE. NO FURTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AF-220 HOLLOW FIBER DIALYZER KDI ALTHIN MEDICAL, AN AFFILIATE OF BHC AF-220 NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death