BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRANUFLO

    MDR report key: 3934473 · Received June 27, 2014

    Report

    Report Number
    1225714-2014-05376
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    March 10, 2007
    Report Date
    May 27, 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 EVENT (CARDIOVASCULAR) OF TWO EVENTS REPORTED FOR THE SAME PT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDRS 1225714-2014-05377, 2937457-2014-01354, 1225714-2014-05378, 1225714-2014-05379 AND 2937457-2014-01355.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PLAINTIFF EXPERIENCED CARDIOVASCULAR EVENTS ON (B)(6) 2007 AND (B)(6) 2013 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375777 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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