BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 3121597 · Received May 16, 2013

    Report

    Report Number
    1225714-2013-00991
    Event Type
    Death
    Date Received
    May 16, 2013
    Date of Event
    April 27, 2011
    Report Date
    May 3, 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 REPORTED EVENT IS ON THE SAME PT INVOLVING TWO SEPARATE PRODUCTS AND ASSOCIATED WITH MDR #1225714-2013-00990.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY. THIS IS ONE OF TWO DEVICE REPORTS ASSOCIATED WITH THIS EVENT. RELATED MANUFACTURER REPORT NUMBERS ARE 1225714-2013-00990 AND 1225714-2013-00991.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT AND SUBSEQUENTLY EXPIRED ON (B)(6) 2011, AFTER THE USE OF THE PRODUCT.

    Description of Event or Problem · 1

    THE ADDITIONAL INFORMATION RECEIVED ALLEGES THE PATIENT EXPERIENCED CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217700 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death