BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURALYTE

    MDR report key: 3233904 · Received July 16, 2013

    Report

    Report Number
    1225714-2013-01249
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    April 20, 2011
    Report Date
    June 21, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K070177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (CARDIOVASCULAR) FOR THE SAME PT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDR # 1225714-2013-01248.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WAS RECEIVED AND NOW INDICATES THE PT EXPERIENCED AN ADVERSE CARDIOVASCULAR EVENT ON TWO OCCASIONS APPROXIMATELY ONE YEAR APART, WHICH IS INCONSISTENT TO THE INITIAL REPORTED INFO. ADDITIONAL INFO REQUESTS FOR PT- AND PRODUCT-SPECIFIC INFO AND COMPLETE DETAILS OF THE EVENT HAVE BEEN MADE ACCORDINGLY. UPON RECEIPT OF ADDITIONAL INFO IT WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO DEVICE REPORTS THAT ARE ASSOCIATED WITH THIS EVENT; ASSOCIATED MANUFACTURER REPORT NUMBER: 1225714-2013-01248.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PLAINTIFF EXPERIENCED A CARDIOVASCULAR EVENT ON (B)(6) 2011, AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329374 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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