BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 4810431 · Received June 1, 2015

    Report

    Report Number
    1225714-2015-03373
    Event Type
    Death
    Date Received
    June 1, 2015
    Date of Event
    July 24, 2008
    Report Date
    May 11, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 PT EXPERIENCED SUDDEN CARDIAC ARREST AND EXPIRED ON THE SAME DAY. THESE CLAIMS WERE ALLEGEDLY CAUSED BY THE PT'S EXPOSURE TO THE PRODUCT WHICH WAS ADMINISTERED DURING THE PT'S DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353192 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L