BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 3809878 · Received April 25, 2014

    Report

    Report Number
    1225714-2014-01705
    Event Type
    Death
    Date Received
    April 25, 2014
    Date of Event
    August 6, 2013
    Report Date
    March 27, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE DEVICE REPORTS RELATED TO THIS EVENT. ASSOCIATED MFR REPORT NUMBERS ARE 1225714-2014-01705, 1225714-2014-021706 AND 2937457-2014-00699. ADD'L INFO AND CLARIFICATION FOR THE EVENT, DATE OF THE EVENT, AND DATE OF DEATH HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (DEATH) FOR THE SAME PT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDRS #1225714-2014-01706 AND 2937457-2014-00699.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2013 AND SUBSEQUENTLY EXPIRED AFTER THE USE OF THE PRODUCT.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED NOTED THAT THE PT EXPERIENCED A SUDDEN CARDIAC EVENT. THE ADD'L INFO REPORTS THE BEST ESTIMATED DATE OF EVENT AND THE DATE OF DEATH AS (B)(6) 2013. HOWEVER, THE INFO PREVIOUSLY RECEIVED FROM THE INITIAL LITIGATION REPORTED THE BEST ESTIMATED DATE OF EVENT AND THE DATE OF DEATH AS (B)(6) 2013. THIS INFO IS BEING REPORTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250890 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death