BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 3847357 · Received May 21, 2014

    Report

    Report Number
    1225714-2014-03314
    Event Type
    Death
    Date Received
    May 21, 2014
    Date of Event
    March 20, 2009
    Report Date
    April 25, 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 (DEATH) FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDRS #1225714-2014-03314 AND 003315.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED SUDDEN RESPIRATORY FAILURE ON OR ABOUT (B)(6) 2009 AND SUBSEQUENTLY EXPIRED AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303669 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death