BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRANUFLO

    MDR report key: 2930399 · Received January 22, 2013

    Report

    Report Number
    1225714-2013-00013
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    October 1, 2004
    Report Date
    May 2, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO DEVICE REPORTS FOR THIS EVENT; THE ASSOCIATED MFR REPORT NUMBERS ARE: 1225714-2013-00013 AND 1225714-2013-00014. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PT EXPERIENCED A CARDIOVASCULAR EVENT. ON OR ABOUT (B)(6) 2004 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28941 GRANUFLO DRY ACID CONCENTRATE FOR BICARBONATE DIALYSIS KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O| S