BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS 2008K

    MDR report key: 3810647 · Received May 6, 2014

    Report

    Report Number
    2937457-2014-00770
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    February 1, 2010
    Report Date
    April 8, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (CARDIOVASCULAR) OF TWO EVENTS REPORTED FOR THE SAME PATIENT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDRS 1225714-2014-02185, 1225714-2014-02186, 1225714-2014-02187, 1225714-2014-02188, 2937457-2014-00770 AND 2937457-2014-00771.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED CARDIOVASCULAR EVENTS ON TWO DIFFERENT DATES IN (B)(6) 2010 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271181 FRESENIUS 2008K KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008K

    Patients

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