BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 4200885 · Received October 22, 2014

    Report

    Report Number
    1225714-2014-13733
    Event Type
    Death
    Date Received
    October 22, 2014
    Date of Event
    March 6, 2011
    Report Date
    February 26, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADDITIONAL INFORMATION RECEIVED ALLEGES THAT THE PATIENT EXPERIENCED THE EVENT APPROXIMATELY FIVE MONTHS PRIOR TO THE EVENT DATE THAT WAS INITIALLY REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO FURTHER CLARIFY THE EVENT DATE AND DETAILS SURROUNDING THE REPORTED EVENT; THIS INFORMATION WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.THIS IS ONE OF TWO DEVICE REPORTS THAT ARE ASSOCIATED WITH THIS EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1225714-2014-13733 AND 1225714-2014-13734.THE HARDCOPY 3500A FORM MFR REPORT # 1225714-2014-13733 FOLLOW-UP # 001 WAS TIMELY SUBMITTED ON (B)(6) 2016 TO THE OFFICE OF CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, STAMPED (B)(6) 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THE DECEDENT EXPERIENCED AN UNSPECIFIED INJURY AND SUBSEQUENTLY EXPIRED ON OR ABOUT (B)(6) 2011 AFTER USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674089 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death