BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 3799052 · Received April 23, 2014

    Report

    Report Number
    1225714-2014-01562
    Event Type
    Death
    Date Received
    April 23, 2014
    Date of Event
    January 9, 2009
    Report Date
    March 27, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K070177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (DEATH) FOR THE SAME PT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDRS #2937457-2014-00632 AND 1225714-2014-01561.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT ON OR ABOUT (B)(6) 2009 THE DECEDENT EXPERIENCED AN UNSPECIFIED INJURY AND SUBSEQUENTLY EXPIRED AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245009 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death