BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 4844398 · Received June 3, 2015

    Report

    Report Number
    1225714-2015-03662
    Event Type
    Death
    Date Received
    June 3, 2015
    Date of Event
    May 8, 2010
    Report Date
    May 15, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K981043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS ONE OF TWO DEVICE REPORTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PT EXPERIENCED THE FOLLOWING INJURY: CARDIAC EVENT AND EXPIRY, CAUSED BY THE PRODUCT ADMINISTERED TO THE PT FOR DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359378 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L