BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURALYTE

    MDR report key: 3810631 · Received May 6, 2014

    Report

    Report Number
    1225714-2014-02182
    Event Type
    Injury
    Date Received
    May 6, 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 EVENTS REPORTED FOR THE SAME PATIENT INVOLVING THREE SEPARATE PRODUCTS; ASSOCIATED MDRS #1225714-2014-02181, 1225714-2014-02182, 1225714-2014-02183, 1225714-2014-02184, 2937457-2014-00768 AND 2937457-2014-00769.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PLAINTIFF EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6), 2012 DURING THE USE OF THE PRODUCT. PATIENT WAS TRANSPORTED TO THE HOSPITAL. PATIENT EXPERIENCED ANOTHER CARDIOVASCULAR EVENT ON (B)(6), 2012 DURING USE OF THE PRODUCT AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271741 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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