BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIKCLOT

    MDR report key: 20782087 · Received November 26, 2024

    Report

    Report Number
    20782087
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    November 14, 2024
    Report Date
    November 15, 2024
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OPENING A PACKAGE OF QUICK CLOT -REF # 487, LOT-44F24G0021. THREE DARK SPOTS NOTED ON THE QUICK CLOT PRIOR TO PLACING THEM ON THE STERILE FIELD. THEY WERE NOT PLACED ON THE STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2411786 QUIKCLOT DRESSING, WOUND, DRUG FRO Z-MEDICA, LLC 0487 44F24G0021

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male