BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 4231680 · Received November 4, 2014

    Report

    Report Number
    1225714-2014-14477
    Event Type
    Death
    Date Received
    November 4, 2014
    Date of Event
    November 15, 2011
    Report Date
    March 3, 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

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ALLEGED THE PATIENT EXPERIENCED THE EVENT 10 DAYS AFTER THE INITIAL REPORTED DATE. THE ADDITIONAL INFORMATION IS NOT SUFFICIENTLY DESCRIPTIVE TO BE RECONCILED WITH OR PROVIDE FURTHER CLARIFICATION TO THE INITIAL SOURCE DOCUMENT INFORMATION. ADDITIONAL INQUIRIES WILL BE SENT TO THE REPORTER TO REQUEST THE DATE OF THE EVENT. ANY INFORMATION RECEIVED WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY. ASSOCIATED MANUFACTURER REPORT NUMBERS: 1225714-2014-14476 AND 1225714-2014-14477. THE HARDCOPY 3500A FORM MFR REPORT # 1225714-2014-14477 FOLLOW-UP # 001 WAS TIMELY SUBMITTED ON 02/19/2016 TO THE OFFICE OF CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, STAMPED 02/19/2016, AND RETURNED TO FRESENIUS MEDICAL CARE WITH A COVER LETTER DATED 02/17/2016 STATING THE PAPER MDR SUBMISSION WAS NOT ACCEPTED. THIS REPORT IS BEING RESUBMITTED ELECTRONICALLY PER 21 CFR PART 803.56.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706347 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death