BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRANUFLO

    MDR report key: 3934451 · Received June 27, 2014

    Report

    Report Number
    1225714-2014-05358
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    October 8, 2010
    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 THREE EVENTS REPORTED FOR THE SAME PATIENT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDRS #1225714-2014-05356, 1225714-2014-05357, 1225714-2014-05358, 1225714-2014-05359, 1225714-2014-05360, 1225714-2014-05361, 2937457-2014-01344, 2937457-2014-01345 AND 2937457-2014-01346.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6), 2010 A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6), 2010 AND SUBSEQUENTLY EXPIRED OR ABOUT (B)(6), 2010 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375731 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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