BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRANUFLO

    MDR report key: 3821305 · Received May 9, 2014

    Report

    Report Number
    1225714-2014-02387
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    January 18, 2012
    Report Date
    April 11, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (CARDIOVASCULAR) OF TWO EVENTS REPORTED ON THE SAME PT INVOLVING TWO SEPARATE PRODUCTS MDRS #1225714-2014-02387, 1225714-2014-02388, 1225714-2014-02389 AND 1225714-2014-02390.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED WEAKNESS, HYPOTENSION AND INADEQUATE FLOW ON (B)(6) 2012 AND A CARDIOVASCULAR EVENT AND SUBSEQUENTLY EXPIRED ON (B)(6) 2012 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282146 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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