BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS 2008K

    MDR report key: 3809940 · Received April 25, 2014

    Report

    Report Number
    2937457-2014-00699
    Event Type
    Death
    Date Received
    April 25, 2014
    Date of Event
    August 16, 2013
    Report Date
    March 27, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    994267
    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 #: 1225714-2014-01706 AND 01705.

    Additional Manufacturer Narrative · 1

    ADD'L INFORMATION RECEIVED NOTED THAT THE PATIENT EXPERIENCED A SUDDEN CARDIAC EVENT. THE ADDITIONAL INFORMATION REPORTS THE BEST ESTIMATED DATE OF EVENT AND THE DATE OF DEATH, AS (B)(6) 2013. HOWEVER, THE INFORMATION PREVIOUSLY RECEIVED FROM THE INITIAL LITIGATION REPORTED THE BEST ESTIMATED DATE OF EVENT AND THE DATE OF DEATH AS (B)(6) 2013. THIS INFORMATION IS BEING REPORTED ACCORDINGLY. THIS IS ONE OF THREE DEVICE REPORTS RELATED TO THIS EVENT. ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1225714-2014-01705, 1225714-2014-021706 AND 2937457-2014-00699. ADDITIONAL INFORMATION AND CLARIFICATION FOR THE EVENT, DATE OF THE EVENT, AND DATE OF DEATH HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2013 AND SUBSEQUENTLY EXPIRED AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251350 FRESENIUS 2008K KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008K

    Patients

    Seq Age Sex Outcome Treatment
    1 Death