BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURALYTE

    MDR report key: 2982352 · Received February 25, 2013

    Report

    Report Number
    1225714-2013-00158
    Event Type
    Injury
    Date Received
    February 25, 2013
    Date of Event
    September 24, 2012
    Report Date
    January 28, 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

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PT EXPERIENCED A CARDIOVASCULAR EVENT ON (B)(6) 2012 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79117 NATURALYTE DRY ACID CONCEMTRATE FOR BICARBONATE DIALYSIS KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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