BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 4810416 · Received June 1, 2015

    Report

    Report Number
    1225714-2015-03362
    Event Type
    Death
    Date Received
    June 1, 2015
    Date of Event
    February 10, 2007
    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
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS 1 OF 2 DEVICE REPORTS FOR THIS EVENT. (B)(4). FOLLOW-UP IS IN PROGRESS TO DETERMINE THE DATE OF DEATH (B2). IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED CARDIAC INJURIES AND/OR RELATED SYMPTOMS AND SUBSEQUENTLY EXPIRED. IT WAS REPORTED THAT THESE EVENTS OCCURRED DUE TO THE ADMINISTRATION OF THE PRODUCT FOR DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353188 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L