BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRANUFLO

    MDR report key: 3841098 · Received May 13, 2014

    Report

    Report Number
    1225714-2014-02521
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    March 22, 2012
    Report Date
    April 16, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (CARDIOVASCULAR) OF TWO EVENTS REPORTED ON THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDRS # 1225714-2014-02521, 1225714-2014-02522, 1225714-2014-02523, AND 1225714-2014-02524.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2012 AND ANOTHER CARDIOVASCULAR EVENT AND SUBSEQUENTLY EXPIRED ON OR ABOUT (B)(6) 2013 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285427 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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