BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 4861372 · Received June 22, 2015

    Report

    Report Number
    1225714-2015-04266
    Event Type
    Death
    Date Received
    June 22, 2015
    Date of Event
    September 26, 2011
    Report Date
    June 10, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO DEVICE REPORTS FOR THIS EVENT. ADD'L INFO HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTY ALLEGED THAT THE PT EXPERIENCED SUDDEN CARDIAC ARREST AND EXPIRED. IT WAS FURTHER ALLEGED THAT THE EVENT WAS CAUSED BY EXPOSURE TO THE PROD ADMINISTERED DURING DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404216 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L