BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 4951488 · Received July 28, 2015

    Report

    Report Number
    1225714-2015-05660
    Event Type
    Death
    Date Received
    July 28, 2015
    Date of Event
    May 23, 2012
    Report Date
    July 20, 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
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO DEVICE REPORTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED A SUDDEN CARDIAC EVENT AND EXPIRED THE NEXT DAY, WHICH IS ALLEGED TO HAVE BEEN CAUSED BY THE PATIENT'S EXPOSURE TO THE PRODUCT ADMINISTERED DURING DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490567 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L