BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS 2008K

    MDR report key: 3888853 · Received June 5, 2014

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    Report

    Report Number
    2937457-2014-00940
    Event Type
    Death
    Date Received
    June 5, 2014
    Date of Event
    June 27, 2011
    Report Date
    May 5, 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 FOR THE SAME PT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDR #1225714-2014-03901,1225714-2014-03902, AND 2937457-2014-00940.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THE DECEDENT EXPIRED ON (B)(6) 2011 AFTER USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329716 FRESENIUS 2008K KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008K

    Patients

    Seq Age Sex Outcome Treatment
    1 Death