BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-STAT

    MDR report key: 1705485 · Received May 18, 2010

    Report

    Report Number
    1705485
    Event Type
    Malfunction
    Date Received
    May 18, 2010
    Date of Event
    May 14, 2010
    Report Date
    May 18, 2010
    Manufacturer
    VASCULAR SOLUTIONS
    Product Code
    MHW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PRODUCT WAS OPENED TO USE AND IT DID NOT MIX APPROPRIATELY. UNABLE TO USE ON PATIENT. HAD TO OPEN ANOTHER ONE TO USE. THIS PRODUCT WAS NEVER USED ON PATIENT AND DID NOT HAVE ANY INTERACTION WITH THE PATIENT.PRODUCT DID NOT MIX PROPERLY AND DID NOT THICKEN.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DOES NOT KNOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-STAT FLOWABLE HEMOSTAT MHW VASCULAR SOLUTIONS 4000 547958

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR NONE KNOWN