BEUDAMED
    FDA Adverse Event Death Summary report: N

    D-STAT FLOWABLE HEMOSTAT

    MDR report key: 4133307 · Received October 1, 2014

    Report

    Report Number
    2134812-2014-00038
    Event Type
    Death
    Date Received
    October 1, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 11, 2014
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    MHW
    PMA / PMN Number
    K012293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    D-STAT FLOWABLE WAS USED DURING A PATIENT PROCEDURE INVOLVING THE REMOVAL OF A PERMA CATHETER. UPON REMOVAL OF THE PERMA CATHETER, THE PHYSICIAN INJECTED D-STAT FLOWABLE AT THE INSERTION SITE AND INTO THE SUBCLAVIAN VEIN. SOON AFTER INJECTING THE D-STAT FLOWABLE, THE PATIENT ARRESTED AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611763 D-STAT FLOWABLE HEMOSTAT HEMOSTAT MHW VASCULAR SOLUTIONS, INC. 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Death