BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURALYTE

    MDR report key: 4231551 · Received November 4, 2014

    Report

    Report Number
    1225714-2014-14463
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    June 1, 2011
    Report Date
    February 26, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K070177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THIS IS ONE OF TWO DEVICE REPORTS RELATED TO THIS EVENT. ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1225714-2014-14462 AND 1225714-2014-14463.ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (CARDIOVASCULAR) FOR THE SAME PT INVOLVING TWO SEPARATE PRODUCTS.

    Description of Event or Problem · 1

    THE INITIAL LITIGATION NOTED THE EVENT AS THE PATIENT EXPERIENCING CARDIAC ARREST. AS PER THE NEW LITIGATION, THE ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT EXPERIENCED A HEART ATTACK.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PLAINTIFF EXPERIENCED A CARDIOVASCULAR EVENT ON AN UNK DATE AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706320 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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