BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 4810444 · Received June 1, 2015

    Report

    Report Number
    1225714-2015-03351
    Event Type
    Death
    Date Received
    June 1, 2015
    Date of Event
    May 29, 2011
    Report Date
    May 15, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS 1 EVENT FOR THE SAME PATIENT INVOLVING 2 SEPARATE PRODUCTS. (B)(4).

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED A CARDIAC EVENT AND EXPIRED. IT WAS REPORTED THAT THE EVENT OCCURRED DUE TO ADMINISTRATION OF THE PRODUCT FOR DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353248 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L