BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 3820441 · Received May 9, 2014

    Report

    Report Number
    1225714-2014-02498
    Event Type
    Death
    Date Received
    May 9, 2014
    Report Date
    March 4, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K070177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT REPORTED ON THE SAME PT INVOLVING TWO SEPARATE PRODUCTS AND ASSOCIATED WITH MDR #1225714-2014-02497 AND 1225714-2014-02498.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO DEVICE REPORTS THAT ARE ASSOCIATED WITH THIS EVENT; THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1225714-2014-02497 AND 1225714-2014-02498. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.

    Description of Event or Problem · 1

    THE ADDITIONAL INFORMATION RECEIVED NOTED THE PATIENT EVENT TO BE BRADYCARDIA ARRHYTHMIA.

    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 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282174 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death