BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 4942001 · Received July 23, 2015

    Report

    Report Number
    1225714-2015-05471
    Event Type
    Death
    Date Received
    July 23, 2015
    Date of Event
    January 25, 2010
    Report Date
    July 15, 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED MULTIPLE SUDDEN CARDIAC EVENTS BETWEEN ONE TO SIX MONTHS APART. APPROXIMATELY EIGHT MONTHS AFTER THE ONSET OF THE FIRST SUDDEN CARDIAC EVENT, THE PATIENT EXPERIENCED CARDIOPULMONARY ARREST AND SUBSEQUENTLY EXPIRED. IT IS FURTHER ALLEGED THAT THE INJURIES AND DEATH WERE CAUSED BY THE PATIENT'S EXPOSURE TO THE PRODUCT ADMINISTERED DURING DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477941 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L