BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRANUFLO

    MDR report key: 2963450 · Received February 13, 2013

    Report

    Report Number
    1225714-2013-00127
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    April 25, 2011
    Report Date
    January 14, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THE PLAINTIFF EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2011 AFTER USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63099 GRANUFLO DRY ACID CONCENTRATE FOR BICARBONATE DIALYSIS KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| O| R| S