BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 3251867 · Received July 25, 2013

    Report

    Report Number
    1225714-2013-01463
    Event Type
    Death
    Date Received
    July 25, 2013
    Report Date
    July 9, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT REPORTED ON THE SAM PT INVOLVING TWO SEPARATE PRODUCTS AND ASSOCIATED WITH MDR #1225714-2013-01464.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED CARDIOVASCULAR EVENT AND SUBSEQUENTLY EXPIRED ON AN UNK DATE AFTER THE USE OF THE PRODUCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348994 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death