BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 4200897 · Received October 22, 2014

    Report

    Report Number
    1225714-2014-13751
    Event Type
    Death
    Date Received
    October 22, 2014
    Date of Event
    January 1, 2011
    Report Date
    February 25, 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

    ADDITIONAL INFORMATION RECEIVED ALLEGED THAT THE PATIENT EXPERIENCED A CARDIAC ARREST (LEADING TO THE PATIENT'S EXPIRATION) APPROXIMATELY TWO AND A HALF MONTHS BEFORE THE INITIALLY REPORTED DATE OF EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO CLARIFY THE EVENT DATE FOR THE ALLEGED PATIENT EXPERIENCE. ANY INFORMATION RECEIVED WILL BE REPORTED UPON RECEIPT ACCORDINGLY. THIS IS ONE OF TWO DEVICE REPORTS THAT ARE ASSOCIATED WITH THIS EVENT; THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1225714-2014-13751 AND 1225714-2014-13752. THE HARDCOPY 3500A FORM MFR REPORT # 1225714-2014-13751 FOLLOW-UP # 001 WAS TIMELY SUBMITTED ON 02/15/2016 TO THE (B)(4), STAMPED 02/15/2016, 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 PT 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 THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674092 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death