BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUIKCLOT HEMOSTATIC AGENT

    MDR report key: 539601 · Received August 16, 2004

    Report

    Report Number
    3004138549-2004-00001
    Event Type
    Injury
    Date Received
    August 16, 2004
    Date of Event
    July 16, 2004
    Report Date
    August 16, 2004
    Manufacturer
    Z-MEDICA LLC
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RESIDENT REAPPLIED ADDITIONAL QUIKCLOT TO A WOUND THAT HAD ALREADY BEEN TREATED WITH QUIKCLOT. THEN THE RESIDENT APPLIED PRESSURE. PT'S HAND BEGAN "SMOKING" AND RESULTED IN A 2ND DEGREE BURN. THIS IS A POTENTIAL ADVERSE EVENT WHEN THE PRODUCT IS NOT USED ACCORDING TO DIRECTIONS. THIS IS CLEARLY STATED IN THE PACKAGE INSTRUCTIONS THAT ARE ATTACHED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other