BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 4890635 · Received July 1, 2015

    Report

    Report Number
    1225714-2015-04580
    Event Type
    Death
    Date Received
    July 1, 2015
    Date of Event
    June 30, 2004
    Report Date
    June 18, 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
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) WAS USED FOR THE CARDIAC EVENT, AS THERE IS NO OTHER CODE AVAILABLE THAT BEST DESCRIBES A NONSPECIFIC CARDIAC EVENT. THIS IS ONE OF TWO DEVICE REPORTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED A CARDIAC EVENT AND EXPIRED ON THAT SAME DATE. FURTHERMORE, IT WAS ALLEGED TO HAVE BEEN CAUSED BY EXPOSURE TO THE PRODUCT ADMINISTERED DURING DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426350 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L