BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS 2008K

    MDR report key: 3954484 · Received July 17, 2014

    Report

    Report Number
    2937457-2014-01684
    Event Type
    Death
    Date Received
    July 17, 2014
    Date of Event
    March 17, 2012
    Report Date
    March 7, 2016
    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

    THE ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT'S CARDIOVASCULAR EVENT (CARDIAC ARREST) WAS RECURRENT IN NATURE. REQUESTS FOR CLARIFICATION AND CIRCUMSTANCES SURROUNDING THE EVENT HAVE BEEN MADE AND WILL BE SUBMITTED ACCORDINGLY UPON RECEIPT. THIS IS ONE OF THREE DEVICE REPORTS THAT ARE ASSOCIATED WITH THIS EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1225714-2014-06479, 1225714-2014-06480, AND 2937457-2014-01684.

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (DEATH) FOR THE SAME PATIENT INVOLVING THREE SEPARATE PRODUCTS.

    Description of Event or Problem · 1

    THE ADDITIONAL INFORMATION RECEIVED ALLEGES THE PATIENT'S EVENT WAS RECURRENT IN NATURE.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2012 AND SUBSEQUENTLY EXPIRED AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420311 FRESENIUS 2008K KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008K

    Patients

    Seq Age Sex Outcome Treatment
    1 Death