BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUIKCLOT HEMOSTATIC AGENT

    MDR report key: 546744 · Received September 24, 2004

    Report

    Report Number
    3004138549-2004-00002
    Event Type
    Injury
    Date Received
    September 24, 2004
    Date of Event
    September 9, 2004
    Report Date
    September 24, 2004
    Manufacturer
    Z-MEDICA LLC
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SAFETY MGR FOR FACILITY TESTED THE PRODUCT ON THEIR HAND USING WATER. THE WATER RESULTED IN A SMALL BURN WITH BLISTERING ON THEIR LEFT PALM THE SIZE OF A QUARTER WITH A RED MARK DOWN THE MIDDLE IN THE CREASE OF THEIR HAND. FACILITY WAS NOT TREATING A WOUND, AND THE PACKAGE INSTRUCTIONS CLEARLY INDICATE THAT WATER CAN CAUSE A BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUIKCLOT HEMOSTATIC AGENT CLASS I STERILE HEMOSTATIC AGENT FRO Z-MEDICA LLC GREEN 0507A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other