BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 3840697 · Received May 13, 2014

    Report

    Report Number
    1225714-2014-02544
    Event Type
    Death
    Date Received
    May 13, 2014
    Date of Event
    June 14, 2010
    Report Date
    April 16, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K070177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT FOR THE SAME PT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDRS # 1225714-2014-02543 AND 1225714-2014-02544.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT ON (B)(6) 2010 THE PT EXPERIENCED A CARDIOVASCULAR EVENT AND RESPIRATORY FAILURE AND AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285353 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R| S