BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRANUFLO

    MDR report key: 3960260 · Received July 15, 2014

    Report

    Report Number
    1225714-2014-06223
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    January 1, 2007
    Report Date
    June 19, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PLAINTIFF EXPERIENCED CARDIOVASCULAR EVENTS ON UNKNOWN DATES IN 2007, 2008 AND 2010 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411904 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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