BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 3845329 · Received May 14, 2014

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    Report

    Report Number
    1225714-2014-02670
    Event Type
    Death
    Date Received
    May 14, 2014
    Date of Event
    August 27, 2007
    Report Date
    April 17, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K070177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (DEATH) OF FOUR EVENTS REPORTED FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDRS: #1225714-2014-02663, 02664, 02665, 02666, 02667, 02668, 02669, AND 02670.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED THREE SEPARATE CARDIOVASCULAR EVENTS ON UNKNOWN DATES IN JULY 2007 AND SUBSEQUENTLY EXPIRED ON OR ABOUT (B)(6) 2007, AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288786 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death