BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 3844950 · Received May 15, 2014

    Report

    Report Number
    1225714-2014-02747
    Event Type
    Death
    Date Received
    May 15, 2014
    Date of Event
    April 19, 2009
    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 TREE EVENTS REPORTED FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDRS #1225714-2014-02743, 1225714-2014-02744, 1225714-2014-02745, 1225714-2014-0273946, 1225714-2014-0273947, AND 1225714-2014-02748.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCE CARDIOVASCULAR EVENTS ON OR ABOUT (B)(6) 2009 AND SUBSEQUENTLY EXPIRED ON (B)(6) 2009, AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289866 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death