BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIKCLOT

    MDR report key: 19971745 · Received August 13, 2024

    Report

    Report Number
    19971745
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    May 17, 2024
    Report Date
    July 16, 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

    DURING THE FIRST COUNT, IT WAS DISCOVERED THAT THERE WAS A QUICK CLOT GAUZE PIECE WAS MISSING. THE SURGICAL FIELD, SURGICAL INCISION, AS WELL AS OUTSIDE OF THE SURGICAL FIELD, ON THE FLOOR, IN THE TRASH CANS, AND UNDER EQUIPMENT WAS SEARCHED. THE QUICK CLOT PIECE WAS NOT FOUND, AND X-RAY WAS CALLED TO COME FOR A FLATPLATE. RADIOLOGIST READ THE X-RAY AS NEGATIVE, AND THIS RESULT WAS COMMUNICATED TO ALL STAFF IN THE ROOM. SURGEON FELT IT WAS APPROPRIATE TO EXPLORE WOUND, SURGICAL SITE REOPENED AT WHICH POINT QUICK GAUZE WAS FOUND AND REMOVED. THIS PRODUCT HAS 1 THIN STRIPE OF RADIOPAQUE MATERIAL, AND IT IS CUT INTRAOPERATIVELY WITH VARIATION AMONG SURGEONS AND SPECIALTIES. THE PRODUCT IS A Z-FOLD 3 IN X 4 YDS. THE PRODUCTS ARE ALL CURRENTLY LABELED AS ¿X-RAY DETECTABLE.¿ WHEN THE X-RAY WAS PERFORMED, THIS PRODUCT WAS NOT SEEN ON THE FILM. IS IT POSSIBLE TO ADD ADDITIONAL RADIOPAQUE AREAS TO THE PRODUCT?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1620020 QUIKCLOT DRESSING, WOUND, DRUG FRO Z-MEDICA, LLC 0487

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male Other