BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 4972564 · Received August 3, 2015

    Report

    Report Number
    1225714-2015-05873
    Event Type
    Death
    Date Received
    August 3, 2015
    Date of Event
    June 27, 2011
    Report Date
    July 28, 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. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ANY ADDITIONAL INFO.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503589 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L