BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 3820222 · Received May 9, 2014

    Report

    Report Number
    1225714-2014-02407
    Event Type
    Death
    Date Received
    May 9, 2014
    Date of Event
    May 6, 2009
    Report Date
    March 9, 2016
    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

    (B)(4). THIS IS ONE OF TWO DEVICE REPORTS FOR THIS EVENT. THE ASSOCIATED MFR REPORT NUMBERS ARE: 1225714-2014-02407 AND 1225714-2014-02408. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT REPORTED ON THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS AND ASSOCIATED WITH MDR 1225714-2014-02407 AND 1225714-2014-02408.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ALLEGED THAT THE PATIENT EXPERIENCED CARDIOGENIC SHOCK, WHICH IS ALLEGED TO HAVE BEEN CAUSED BY THE PRODUCT ADMINISTERED TO THE PATIENT FOR DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281783 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death