BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS 2008K

    MDR report key: 3934543 · Received June 27, 2014

    Report

    Report Number
    2937457-2014-01331
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    December 6, 2010
    Report Date
    May 27, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (CARDIOVASCULAR) OF TWO EVENTS FOR THE SAME PATIENT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDRS 1225714-2014-05332, 1225714-2014-05333 AND 2937457-2014-01331.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PLAINTIFF EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2010 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376002 FRESENIUS 2008K KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008K

    Patients

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