BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRANUFLO

    MDR report key: 3951753 · Received July 2, 2014

    Report

    Report Number
    1225714-2014-05797
    Event Type
    Injury
    Date Received
    July 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF FIVE EVENTS (CARDIOVASCULAR) FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PLAINTIFF EXPERIENCED 5 CARDIOVASCULAR EVENTS ON OR ABOUT 2009 TO (B)(6) 2012 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385678 GRANUFLO KPO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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