BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 4810442 · Received June 1, 2015

    Report

    Report Number
    1225714-2015-03356
    Event Type
    Death
    Date Received
    June 1, 2015
    Date of Event
    November 10, 2011
    Report Date
    May 15, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K981043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS 1 EVENT FOR THE SAME PATIENT INVOLVING 2 SEPARATE PRODUCTS. THE EXACT DATE OF DEATH WAS NOT REPORTED AND IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED SUDDEN CARDIAC ARREST AND SUBSEQUENTLY EXPIRED. IT WAS REPORTED THAT THE EVENT OCCURRED DUE TO ADMINISTRATION OF THE PRODUCT FOR DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353512 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L