BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURALYTE

    MDR report key: 3082487 · Received April 25, 2013

    Report

    Report Number
    1225714-2013-00702
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    January 1, 2009
    Report Date
    March 29, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K070177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (CARDIOVASCULAR) OF THREE EVENTS REPORTED ON THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS AND ASSOCIATED WITH MDRS # 1225714-2013-00699, 1225714-2013-00700, 1225714-2013-00701, 1225714-2013-00703, 1225714-2013-00704.

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED THAT THE PLAINTIFF EXPERIENCED THREE CARDIOVASCULAR EVENTS IN 2009 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179779 NATURALYTE DRY ACID CONCENTRATE FOR BIOCARBONATE DIALYSIS KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| L| O| R| S