BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 3900069 · Received May 27, 2014

    Report

    Report Number
    1225714-2014-03472
    Event Type
    Death
    Date Received
    May 27, 2014
    Date of Event
    April 1, 2008
    Report Date
    April 29, 2014
    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 EVENT (CARDIOVASCULAR) OF TWO EVENT REPORTED FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS: ASSOCIATED MDRS #1225714-2014-03472 AND 1225714-2014-03473.

    Additional Manufacturer Narrative · 1

    ADD'L REVIEW OF THE INFO RECEIVED FROM THE INITIAL REPORTER HAS LED TO THE CONCLUSION THAT THE PT EXPIRED SUBSEQUENT TO THE EVENT. THIS IS ONE EVENT FOR THE SAME PT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MFR REPORT NUMBERS: 1225714-2014-03472 AND 1225714-2014-03473. ADD'L INFO HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.

    Description of Event or Problem · 1

    THE PATIENT EXPIRED SUBSEQUENT TO THE EVENT.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED A CARDIOVASCULAR EVENT ON (B)(6) 2008, AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312020 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| O| R| S