BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 5067123 · Received September 8, 2015

    Report

    Report Number
    1225714-2015-07133
    Event Type
    Death
    Date Received
    September 8, 2015
    Date of Event
    April 20, 2009
    Report Date
    August 28, 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 OF TWO DEVICE REPORTS RELATED TO THIS EVENT. ADDITIONAL INFO HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTY ALLEGED THAT THE PATIENT EXPERIENCED A SUDDEN CARDIAC EVENT AND APPROXIMATELY 3 DAYS LATER EXPERIENCED ANOTHER SUDDEN CARDIAC EVENT. APPROXIMATELY 11 DAYS AFTER THE FIRST ONSET OF EVENTS, THE PATIENT EXPERIENCED ANOTHER SUDDEN CARDIAC EVENT AND EXPIRED ON THE NEXT DAY, WHICH IS ALLEGED TO HAVE BEEN CAUSED BY THE PATIENT'S EXPOSURE TO THE PRODUCT ADMINISTERED DURING DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592163 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L