BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 5060305 · Received September 3, 2015

    Report

    Report Number
    1225714-2015-07030
    Event Type
    Death
    Date Received
    September 3, 2015
    Date of Event
    January 1, 2010
    Report Date
    August 26, 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 RELATED TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED A SUDDEN CARDIAC EVENT AND EXPIRED THE SAME DAY. IT WAS ALLEGED THAT THE EVENT OCCURRED DUE TO EXPOSURE OF THE PRODUCT ADMINISTERED WHILE RECEIVING DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586156 GRANUFLO KPO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L