BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS 2008K

    MDR report key: 3934145 · Received June 27, 2014

    Report

    Report Number
    2937457-2014-01346
    Event Type
    Death
    Date Received
    June 27, 2014
    Date of Event
    October 10, 2010
    Report Date
    May 27, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (DEATH) OF THREE EVENTS REPORTED FOR THE SAME PATIENT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDRS # 1225714-2014-05356, 1225714-2014-05357, 1225714-2014-05358, 1225714-2014-05359, 1225714-2014-05360, 1225714-2014-05361, 2937457-2014-01344, 2937457-2014-01345, AND 2937457-2014-01346.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2010, A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2010 AND SUBSEQUENTLY EXPIRED ON ABOUT (B)(6) 2010 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377758 FRESENIUS 2008K KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008K

    Patients

    Seq Age Sex Outcome Treatment
    1 Death