BEUDAMED
    FDA Adverse Event Death Summary report: N

    D-STAT FLOWABLE HEMOSTAT

    MDR report key: 845099 · Received May 3, 2007

    Report

    Report Number
    2134812-2007-00006
    Event Type
    Death
    Date Received
    May 3, 2007
    Date of Event
    February 22, 2007
    Report Date
    May 3, 2007
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    MHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMISSION OF THIS REPORT DOES NOT REPRESENT A CONCLUSION OR ADMISSION BY VASCULAR SOLUTIONS, INC., THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, OR THAT THE DEVICE FAILED OR MALFUNCTIONED IN ANY MANNER OR THAT THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OF ANY PERSON.

    Description of Event or Problem · 1

    FOLLOWING A LIVER BIOPSY PROCEDURE, 5CC OF D-STAT FLOWABLE WAS INJECTED INTO THE TISSUE TRACT OF THE BIOPSY ACCESS SITE. THE PATIENT TOLERATED THE DELIVERY OF THE PROCOAGULANT WITHOUT ANY INDICATION OF PROBLEMS OR CHANGES IN VITAL SIGNS; HOWEVER, WHEN THE PATIENT SAT UP TO BE TRANSFERRED INTO A WHEELCHAIR, HE BECAME UNCONSCIOUS AND CODED. THE PATIENT WAS RESUSCITATED, BUT EXPIRED 15 DAYS LATER. PLEASE NOTE THAT USE OF THE D-STAT FLOWABLE PRODUCT IN THIS MANNER REPRESENTED AN OFF-LABEL USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-STAT FLOWABLE HEMOSTAT TOPICAL HEMOSTAT MHW VASCULAR SOLUTIONS, INC. 4000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death