BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRANUFLO

    MDR report key: 3082207 · Received April 25, 2013

    Report

    Report Number
    1225714-2013-00679
    Event Type
    Injury
    Date Received
    April 25, 2013
    Report Date
    March 28, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT IS THE SAME PT INVOLVING TWO SEPARATE PRODUCTS AND ASSOCIATED WITH MDR # 1225714-2013-00680.

    Description of Event or Problem · 1

    THE PLAINTIFF ALLEGED THAT HE EXPERIENCED A ILL DEFINED EVENT ON NI/NI/NI AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179669 GRANUFLO DRY ACID CONCENTRATE FOR BICARBONATE DIALYSIS KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R| S