BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 4012252 · Received July 30, 2014

    Report

    Report Number
    1225714-2014-07160
    Event Type
    Death
    Date Received
    July 30, 2014
    Report Date
    July 8, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (DEATH) OF TWO EVENTS REPORTED FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS. THE SF LAWSUIT STATES THAT THE PLAINTIFF SUFFERED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2011 AND SUBSEQUENTLY EXPIRED ON (B)(6) 2011. THE DATES OF THE CARDIOVASCULAR EVENT AND DEATH HAS BEEN RECORDED AS UNKNOWN. HOWEVER, UPON RECEIPT OF ADDITIONAL INFORMATION, MEDICAL RECORDS AND OR CLARIFICATION OF THE EVENT DATES WILL BE REASSESSED ACCORDINGLY.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON AN UNKNOWN DATE AND SUBSEQUENTLY EXPIRED ON A LATER DATE AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444348 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death