BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 4948787 · Received July 27, 2015

    Report

    Report Number
    1225714-2015-05559
    Event Type
    Death
    Date Received
    July 27, 2015
    Date of Event
    June 30, 2010
    Report Date
    July 20, 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 FOR THIS EVENT. ADD'L INFO HAS BEEN REQUESTED & WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTY ALLEGED THAT THE PATIENT EXPERIENCED A CARDIAC ARRHYTHMIA & SUBSEQUENTLY EXPIRED, 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
    485578 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L