BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D-STAT FLOWABLE HEMOSTAT

    MDR report key: 585140 · Received March 25, 2005

    Report

    Report Number
    2134812-2005-00447
    Event Type
    Injury
    Date Received
    March 25, 2005
    Date of Event
    March 4, 2005
    Report Date
    March 25, 2005
    Manufacturer
    VASCULAR SOLUTIONS
    Product Code
    MHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    D-STAT FLOWABLE HEMOSTAT WAS USED FOLLOWING A LIVER BIOPSY. THE PT DEVELOPED HYPOXIA, LOSS OF BLOOD PRESSURE, AND STOPPED BREATHING. THE PT WAS RESUSCITATED, THEN WAS MONITORED IN INTENSIVE CARE FOR 2 DAYS. THE EVENT WAS RESOLVED WITH NO FURTHER COMPLICATIONS. NO DIAGNOSTIC STUDIES WERE COMPLETED TO DETERMINE THE CAUSE OF THIS EVENT; HOWEVER, THE PHYSICIAN SUSPECTED THAT A SMALL AMOUNT OF D-STAT FLOWABLE HEMOSTAT MAY HAVE ENTERED THE VASCULATURE OF THE LIVER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention