BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS 2008K

    MDR report key: 3934900 · Received June 23, 2014

    Report

    Report Number
    2937457-2014-01210
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    December 27, 2010
    Report Date
    May 23, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ONE EVENT (CARDIOVASCULAR) OF TWO EVENTS REPORTED FOR THE SAME PATIENT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDRS #2937457-2014-01210, 2937457-2014-01211, 1225714-2014-05128, 1225714-2014-05129, 1225714-2014-05130 AND 1225714-2014-05131.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2010, DURING USE OF THE PRODUCT AND SUBSEQUENTLY EXPIRED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367138 FRESENIUS 2008K KPO KPO FRESENIUS MEDICAL CARE NORTH AMERICA 2800K

    Patients

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