BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURALYTE

    MDR report key: 3980102 · Received June 25, 2014

    Report

    Report Number
    1225714-2014-06017
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    September 30, 2011
    Report Date
    June 9, 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 OF TWO EVENTS (CARDIOVASCULAR) REPORTED FOR THE SAME PATIENT INVOLVING THREE SEPARATE PRODUCTS.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371414 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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