BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 3812755 · Received May 2, 2014

    Report

    Report Number
    1225714-2014-02035
    Event Type
    Death
    Date Received
    May 2, 2014
    Date of Event
    November 10, 2012
    Report Date
    April 4, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT OF THE EVENT INDICATED THE PATIENT MAY HAVE EXPIRED AND AS THE DEATH CANNOT BE RULED OUT DUE TO INCOMPLETE REPORTED INFORMATION, A CORRECTION TO THE TYPE OF REPORTABLE EVENT IS BEING MADE TO REFLECT "DEATH". FURTHER, ADDITIONAL INFORMATION WAS RECEIVED AND NOTED THE PATIENT EXPERIENCED THE EVENT TWO YEARS PRIOR TO WHAT WAS INITIALLY REPORTED. REQUEST TO OBTAIN COMPETE, CLEAR DETAILS SURROUNDING THE EVENT INCLUDING THE EVENT DATE ARE BEING MADE AND UPON RECEIPT WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THIS EVENT UNDER MANUFACTURER REPORT NUMBERS 1225714-2014-02035 AND 1225714-2014-02036.

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (CARDIOVASCULAR) FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDRS #1225714-2014-02035 AND 02036.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED ALKALOSIS AND A CARDIOVASCULAR EVENTS BEGINNING ON OR ABOUT (B)(6), 2012 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265334 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| O| R| S