BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 3113556 · Received May 10, 2013

    Report

    Report Number
    1225714-2013-00940
    Event Type
    Death
    Date Received
    May 10, 2013
    Date of Event
    May 4, 2011
    Report Date
    May 2, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K070177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (DEATH) OF TWO EVENTS REPORTED ON THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS AND ASSOCIATED WITH MDR NUMBERS: 1225714-2013-00937, 1225714-2013-00938, 1225714-2013-00939.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED, THE DECEDENT UNDERWENT DIALYSIS TREATMENT ON (B)(6) 2011; WHILE AT (B)(6) THE DECEDENT PASSED OUT AND WAS ADMITTED TO THE HOSPITAL IN ICU, WHERE THE DECEDENT PASSED OUT AGAIN FOR ANOTHER 30 MINUTES AND WENT INTO A COMA. THE TESTS REVEALED THAT THE DECEDENT SUFFERED BRAIN DAMAGE. THE DECEDENT WAS TAKEN OFF LIFE SUPPORT TWO DAYS BEFORE HIS DEATH, AND SUBSEQUENTLY EXPIRED ON (B)(6) 2011 AFTER USE OF THE PRODUCT. THE PLAINTIFF'S ATTORNEY ALSO ALLEGED THE DECEDENT'S DEATH CERTIFICATE LISTS BOTH ANOXIC BRAIN INJURY AND CARDIAC ARREST AS CAUSES OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206030 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death