BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 3847530 · Received May 19, 2014

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    Report

    Report Number
    1225714-2014-02796
    Event Type
    Death
    Date Received
    May 19, 2014
    Date of Event
    July 24, 2007
    Report Date
    April 18, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (DEATH) OF TWO EVENTS REPORTED ON THE SAME PT INVOLVING TWO SEPARATE PRODUCTS AND ASSOCIATED WITH MDRS # 1225714-2014-02794, 1225714-2014-02795, 1225714-2014-02796 AND 1225714-2014-02797.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2007 AND SUBSEQUENTLY EXPIRED ON (B)(6) 2007 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295750 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death