BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QC Z-FOLD HEMOSTATIC DRESSING,10X

    MDR report key: 23941958 · Received January 2, 2026

    Report

    Report Number
    3004138549-2025-00006
    Event Type
    Injury
    Date Received
    January 2, 2026
    Date of Event
    December 5, 2025
    Report Date
    December 8, 2025
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    QSY
    PMA / PMN Number
    K123387
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER PROVIDED INFORMATION CLAIMS QUIKCLOT WAS USED DURING CARDIOVASCULAR SURGERY. PER THE IFU INDICATIONS FOR USE STATE THE PRO DUCT "INTENDED USE AS A TOPICAL DRESSING", IFU WARNINGS STATE "PRODUCT IS NOT ABSORBABLE AND MUST BE REMOVED FROM WOUND PRIOR TO WOUND CLOSURE." BASED UPON CUSTOMER STATEMENTS THE PRODUCT WAS USED OUTSIDE INDICATIONS FOR USE. PER THE CUSTOMER CLAIM THE SURGEON RE -OPENED THE PATIENT'S CHEST AFTER SURGERY TO CHECK FOR THE GAUZE, NONE WAS FOUND. THE PRODUCT 487 IS 7.6CM WIDE AND 3.7M IN LENGTH. THIS EQUATES TO A MASS THAT EQUALS 10.66CM SQUARE. THE SIZE OF THE GAUZE IN EITHER CUBIC MASS OR LENGTH SHOULD BE APPARENT TO THE SURGEON. THE RADIOPAQUE (X-RAY) THREAD USED IN THIS PRODUCT HAS A COMPOSITION BY WEIGHT EQUALING 60% MINIMUM BARIUM SULPHATE. AS PART PRODUCT SPECIFICATION EACH LOT OF RADIOPAQUE (X-RAY) THREAD IS TESTED, AND A CERTIFICATE OF CONFORMANCE IS SUPPLIED BY THE VENDOR. THIS CONCLUSION HAS DETERMINED TWO FACTS. 1) CUSTOMER SUPPLIED INFORMATION INDICATES THE CUSTOMER IS USING THE PRODUCT OFF LABEL. 2) THERE IS NO INDICATION THROUGH HISTORICAL REVIEW OF PRODUCTION AND COMPLAINT RECORDS AND RADIOPAQUE (X-RAY) THREAD TESTING OF EACH LOT THAT WOULD SUBSTANTIATE THE INABILITY OF THE RADIOPAQUE (X-RAY) THREAD TO PERFORM AS INTENDED. BASED ON THIS INVESTIGATION IT DOES NOT APPEAR THERE WAS FAILURE OF THE DEVICE TO PERFORM AS INTENDED AND IS ATTRIBUTABLE TO USER ERROR. COMPLAINT INFORMATION WILL BE SUBJECTED TO TRENDING; ACTIONS WILL BE TAKEN IF TRENDING INDICATES AN ADVERSE TREND OR IF ADDITIONAL I NFORMATION IS MADE AVAILABLE WHICH WOULD CHANGE THE POSITION OF THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT; "QUIKCLOT WAS USED DURING CARDIOVASCULAR SURGERY, BUT THE GAUZE COUNT WAS INCORRECT. THE SURGEON REOPENED THE PATIENT'S CHEST AFTER SURGERY AND CHECKED, BUT THE GAUZE WAS NOT FOUND. THE PATIENT WAS X-RAYED, BUT THE X-RAY CONTRAST THREAD DID NOT SHOW UP. ANOTHER QUIKCLOT WAS X-RAYED OUTSIDE THE BODY, BUT THE RADIOPAQUE THREAD DID NOT SHOW UP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4639 QC Z-FOLD HEMOSTATIC DRESSING,10X HEMOSTATIC WOUND DRESSING WITH QSY Z-MEDICA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED.