BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 4840166 · Received June 11, 2015

    Report

    Report Number
    1225714-2015-03925
    Event Type
    Death
    Date Received
    June 11, 2015
    Date of Event
    April 12, 2010
    Report Date
    June 4, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO DEVICE REPORTS RELATED TO THIS EVENT. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ANY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383125 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death