BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRANUFLO

    MDR report key: 2896025 · Received January 2, 2013

    Report

    Report Number
    1225714-2013-00006
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    February 23, 2010
    Report Date
    December 7, 2012
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE ATTORNEY ALLEGED ON (B)(6) 2010, DURING WORK HOURS AF A DIALYSIS CLINIC THE CLINIC WORKER/PLAINTIFF WAS ATTEMPTING TO PLACE GRANUFLO INTO THE MIXER AND A PORTION BLEW INTO THE AIR AND WENT INTO HER NOSTRILS AND EYES. THE ATTORNEY ALLEGES SERIOUS, PERMANENT INJURIES, DISABILITY, MEDICAL TREATMENT AND DISCOMFORT AS A RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R| S FRESENIUS MEDICAL CARE GRANMIXER