BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURALYTE

    MDR report key: 3850494 · Received May 20, 2014

    Report

    Report Number
    1225714-2014-02981
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    August 1, 2007
    Report Date
    April 22, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE
    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 (CEREBROVASCULAR) OF TWO EVENTS REPORTED FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDRS #1225714-2014-02980, 1225714-2014-02981, 1225714-2014-02982, AND 1225714-2014-02983.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CEREBROVASCULAR EVENT ON OR ABOUT (B)(6) 2007 AND SUBSEQUENTLY EXPIRED ON (B)(6) 2007, AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298998 NATURALYTE KPO KPO FRESENIUS MEDICAL CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R| S