BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURALYTE

    MDR report key: 3820753 · Received May 7, 2014

    Report

    Report Number
    1225714-2014-02220
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    July 1, 2011
    Report Date
    April 9, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K070177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (CARDIOVASCULAR) OF TWO EVENTS REPORTED FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDR 1225714-2014-02217, 1225714-2014-02218, 1225714-2014-02219 AND 1225714-2014-02220.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON (B)(6) 2010 AND A CARDIOVASCULAR EVENT (B)(6) 2011 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276693 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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