BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRANUFLO

    MDR report key: 3935883 · Received June 23, 2014

    Report

    Report Number
    1225714-2014-05060
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    January 3, 2013
    Report Date
    May 23, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE EVENTS (CARDIOVASCULAR) FOR THE SAME PT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDRS 1225714-2014-05056, 1225714-2014-05057, 1225714-2014-05058, 1225714-2014-05059, 1225714-2014-05061, 2937457-2014-01171, 2937457-2014-01172 AND 2937457-2014-01173.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PT EXPERIENCED CARDIOVASCULAR EVENTS ON OR ABOUT (B)(6) 2010, (B)(6) 2012 AND (B)(6) 2013 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366815 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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