BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 5009845 · Received August 14, 2015

    Report

    Report Number
    1225714-2015-06381
    Event Type
    Death
    Date Received
    August 14, 2015
    Date of Event
    June 13, 2003
    Report Date
    August 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

    CODE (B)(4) WAS ADDED TO THE PATIENT CODES FOR THE CARDIAC EVENT SINCE THERE IS NO CODE AVAILABLE THAT BEST DESCRIBES AN UNSPECIFIED CARDIAC EVENT. 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 CARDIAC EVENT AND SUBSEQUENTLY EXPIRED, 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
    538061 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L