BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURALYTE

    MDR report key: 3900070 · Received May 27, 2014

    Report

    Report Number
    1225714-2014-03437
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    January 26, 2012
    Report Date
    April 28, 2014
    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 TWO EVENT REPORTED FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS: ASSOCIATED MDRS #1225714-2014-03436, 1225714-2014-03437, 1225714-2014-03438, AND 1225714-2014-03439.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2012 AND SUBSEQUENTLY EXPIRED ON (B)(6) 2012, AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312086 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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