BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS 2008K

    MDR report key: 3810838 · Received April 25, 2014

    Report

    Report Number
    2937457-2014-00703
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    July 1, 2012
    Report Date
    March 27, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (CARDIOVASCULAR) FOR THE SAME PT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDRS # 1225714-2014-01714 AND 1225714-2014-01713.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PT EXPERIENCED A CARDIOVASCULAR EVENT ON (B)(6) 2012, AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250650 FRESENIUS 2008K KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008K

    Patients

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