BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 3594374 · Received January 21, 2014

    Report

    Report Number
    1225714-2014-00170
    Event Type
    Death
    Date Received
    January 21, 2014
    Date of Event
    March 13, 2012
    Report Date
    January 7, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K070177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO DEVICE REPORTS RELATED TO THIS EVENT. THIS EVENT IS ONE OF TWO EVENT RELATED TO THIS SAME PATIENT. THIS EVENT IS ASSOCIATED WITH MFR REPORT NUMBERS 1225714-2013-00169 AND 1225714-2014-00170. THE OTHER EVENT FOR THIS PATIENT IS ASSOCIATED WITH MFR REPORT NUMBERS 1225714-2015-081168 AND 1225714-2015-08119. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (DEATH) FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS: ASSOCIATED MDRS #1225714-2014-00169 AND 1225714-2014-00170.

    Description of Event or Problem · 1

    THE ADDITIONAL INFORMATION RECEIVED ALLEGED THAT THE PATIENT EXPERIENCED A CARDIAC EVENT THAT WAS SUDDEN IN NATURE AND EXPIRED ON THAT SAME DAY, WHICH IS ALLEGED TO HAVE BEEN CAUSED BY THE PATIENT 'S EXPOSURE TO THE PRODUCT ADMINISTERED DURING DIALYSIS TREATMENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50752 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death