BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURALYTE

    MDR report key: 3214044 · Received July 3, 2013

    Report

    Report Number
    1225714-2013-01232
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    November 17, 2012
    Report Date
    June 14, 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 (CARDIOVASCULAR) OF THREE EVENTS REPORTED ON THE SAME PT INVOLVING TWO SEPARATE PRODUCTS AND ASSOCIATED WITH MEDWATCH #S 1225714-2013-00909, 1225714-2013-00910, 1225714-2013-00911, 1225714-2013-00912; 1225714-2013-01231.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED CARDIOVASCULAR EVENTS ON (B)(6) 2012; SUBSEQUENTLY EXPIRED ON (B)(6) 2012, AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304807 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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