BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 3093993 · Received May 1, 2013

    Report

    Report Number
    1225714-2013-00782
    Event Type
    Death
    Date Received
    May 1, 2013
    Date of Event
    January 1, 2007
    Report Date
    April 8, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT IS ON THE SAME PT INVOLVING TWO SEPARATE PRODUCT AND ASSOCIATED WITH MEDWATCH #1225714-2013-00783.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189245 GRANUFLO DRY ACID CONCENTRATE FOR BICARBONATE DIALYSIS KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death