BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURALYTE

    MDR report key: 3242962 · Received July 19, 2013

    Report

    Report Number
    1225714-2013-01273
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    October 4, 2011
    Report Date
    June 28, 2013
    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 IS ONE EVENT (CARDIOVASCULAR) OF THREE EVENTS REPORTED ON THE SAME PT INVOLVING TWO SEPARATE PRODUCTS AND ASSOCIATED WITH MDRS # 1225714-2013-01270, 1225714-2013-01271, 1225714-2013-01272, 1225714-2013-01273, 1225714-2013-01275.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THE PLAINTIFF EXPERIENCED MULTIPLE CEREBROVASCULAR EVENTS ON (B)(6) 2011 AND (B)(6) 2012, AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338780 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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