BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 3890248 · Received June 11, 2014

    Report

    Report Number
    1225714-2014-04322
    Event Type
    Death
    Date Received
    June 11, 2014
    Date of Event
    May 28, 2011
    Report Date
    May 12, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCT IDENTIFIER WAS PROVIDED HOWEVER, THE DATES OF USAGE WAS NOT INDICATED THEREFORE, THE PRODUCT WILL BE REVIEWED IN THE PLANT'S THREE MONTH RETROSPECTIVE REVIEW: GRANUFLO 2325 3K2.5CA 0.75MG 15.5 GAL. THIS IS ONE EVENT (DEATH) FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDR 1225714-2014-04322 AND 1225714-2014-04323.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPIRED ON OR ABOUT (B)(6) 2011 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345375 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death