BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 3840704 · Received May 13, 2014

    Report

    Report Number
    1225714-2014-02541
    Event Type
    Death
    Date Received
    May 13, 2014
    Date of Event
    April 13, 2007
    Report Date
    April 16, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT FOR THE SAME PT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDRS # 1225714-2014-02541 AND 1225714-2014-02542.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO DEVICE REPORTS RELATED TO THIS EVENT. ASSOCIATED MFR REPORT NUMBERS ARE 1225714-2014-02541 AND 1225714-2014-02542. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT ON (B)(6) 2012 THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT AND SUBSEQUENTLY EXPIRED AFTER THE USE OF THE PRODUCT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT EXPERIENCED A CARDIAC ARREST AND APPROXIMATELY FIVE YEARS LATER EXPERIENCED A MYOCARDIAL INFARCTION AND EXPIRED ON THAT SAME DAY. IT WAS FURTHER ALLEGED THAT THE EVENT WAS CAUSED BY ADMINISTRATION OF THE PRODUCT FOR DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285522 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death