BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANFULO

    MDR report key: 3288811 · Received August 6, 2013

    Report

    Report Number
    1225714-2013-02046
    Event Type
    Death
    Date Received
    August 6, 2013
    Date of Event
    September 22, 2007
    Report Date
    July 15, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO DEVICE REPORTS FOR THIS EVENT. ASSOCIATED MFR REPORT NUMBERS: 1225714-2013-02046 AND 1225714-2013-02047. ADD'L INFO HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT FOR THE SAME PT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDRS NUMBERS: 1225714-2013-46, 1225714-2013-02047.

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED ALLEGED THAT THE PT EXPERIENCED CARDIAC ARREST, WHICH IS ALLEGED TO HAVE BEEN CAUSED BY THE PRODUCT ADMINISTERED TO THE PT FOR DIALYSIS TREATMENT.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT AND SUBSEQUENTLY EXPIRED ON (B)(6) 2007 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369259 GRANFULO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death