BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 3040001 · Received April 3, 2013

    Report

    Report Number
    1225714-2013-00441
    Event Type
    Death
    Date Received
    April 3, 2013
    Date of Event
    October 3, 2007
    Report Date
    March 7, 2013
    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
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (DEATH) OF TWO EVENTS REPORTED AND ASSOCIATED WITH MDR #S 1225714-2013-00439, 1225714-2013-00440, 1225714-2013-00442.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON (B)(6) 2007, AND SUBSEQUENTLY EXPIRED ON (B)(6) 2007, AFTER USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137434 GRANUFLO DRY ACID CONCENTRATE FOR BICARBONATE DIALYSIS KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death