BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRANUFLO

    MDR report key: 3242848 · Received July 19, 2013

    Report

    Report Number
    1225714-2013-01276
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    May 16, 2011
    Report Date
    June 24, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (INJURY) OF TWO EVENTS REPORTED FOR THE SAME PT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDR #S: 1225714-2013-01276 1225714-2013-01277, 225714-2013-01090, 225714-2013-01091.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED AN UNSPECIFIED INJURY ON (B)(6) 2011, EXPERIENCED A CARDIOVASCULAR EVENT AND SUBSEQUENTLY EXPIRED AFTER THE USE OF THE PRODUCT. THE DECEDENT'S CERTIFICATE OF DEATH WAS REC'D INDICATING IMMEDIATE CAUSE OF DEATH WAS ACUTE MYOCARDIAL INFARCTION AND THE OTHER SIGNIFICANT CONDITION WAS SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338877 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| O| R| S