BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRANUFLO

    MDR report key: 3950041 · Received June 27, 2014

    Report

    Report Number
    1225714-2014-05418
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    December 1, 2011
    Report Date
    May 28, 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 TWO EVENTS REPORTED FOR THE SAME PT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDR #1225714-2014-05416, 1225714-2014-05417, 1225714-2014-05418 AND 1225714-2014-05419.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DESCENDENT EXPERIENCED CARDIOVASCULAR EVENTS IN (B)(6) 2011 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376769 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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