BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 4861414 · Received June 22, 2015

    Report

    Report Number
    1225714-2015-04263
    Event Type
    Death
    Date Received
    June 22, 2015
    Date of Event
    July 28, 2012
    Report Date
    June 10, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K981043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT FOR THE SAME PT INVOLVING TWO SEPARATE PROD. ADD'L INFO HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.

    Description of Event or Problem · 1

    THE PT'S ATTY ALLEGED THAT THE PT EXPERIENCED A CARDIAC ARREST AND SUBSEQUENTLY EXPIRED, WHICH MY HAVE BEEN CAUSED BY EXPOSURE TO THE PROD ADMINISTERED DURING DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403647 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L