BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS 2008K

    MDR report key: 3870414 · Received June 2, 2014

    Report

    Report Number
    2937457-2014-00900
    Event Type
    Death
    Date Received
    June 2, 2014
    Date of Event
    January 1, 2011
    Report Date
    April 30, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT FOR THE SAME PT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDR #1225714-2014-03720 AND 1225714-2014-03721.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CEREBROVASCULAR AND A CARDIOVASCULAR EVENT IN 2011 AND SUBSEQUENTLY EXPIRED AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322150 FRESENIUS 2008K KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008K

    Patients

    Seq Age Sex Outcome Treatment
    1 Death