BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 4101417 · Received September 3, 2014

    Report

    Report Number
    1225714-2014-10358
    Event Type
    Death
    Date Received
    September 3, 2014
    Date of Event
    January 16, 2007
    Report Date
    August 18, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ALLEGED THE PATIENT EXPERIENCED A CARDIAC EVENT. THE ADDITIONAL INFORMATION IS NOT SUFFICIENTLY DESCRIPTIVE TO BE RECONCILED WITH OR PROVIDE FURTHER CLARIFICATION TO THE INITIAL SOURCE DOCUMENT INFORMATION. AS SUCH, THE DATE INITIALLY PROVIDED IS BEST ESTIMATE PENDING CONFIRMATION AND OR CLARIFICATION FROM THE REPORTER. ADDITIONAL INQUIRIES WILL BE SENT TO THE REPORTER TO CLARIFY THE OCCURRENCE DATE. ANY INFORMATION RECEIVED WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY. ASSOCIATED MANUFACTURER REPORT NUMBERS: 1225714-2014-10358 AND 1225714-2014-10359.

    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 THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2007 AND SUBSEQUENTLY EXPIRED AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535703 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death