BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURALYTE

    MDR report key: 3950127 · Received June 27, 2014

    Report

    Report Number
    1225714-2014-05555
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    July 2, 2009
    Report Date
    May 29, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K070177
    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 REPORTED FOR THE SAME PT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDR # 1225714-2014-05554, 1225714-2014-05555, 1225714-2014-05556, 1225714-2014-05557, 2937457-2014-01406 AND 2937457-2014-01407.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6), 2009 AND SUBSEQUENTLY EXPIRED ON (B)(6), 2009 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376797 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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