BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUIKCLOT HEMOSTATIC DRESSING

    MDR report key: 7210361 · Received January 22, 2018

    Report

    Report Number
    3004138549-2018-00001
    Event Type
    Injury
    Date Received
    January 22, 2018
    Date of Event
    January 19, 2018
    Report Date
    January 22, 2018
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    FRO
    PMA / PMN Number
    K123387
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS INADVERTENTLY LEFT INSIDE THE PATIENT. NO INFORMATION ABOUT SPECIFIC PART NUMBER, LOT NUMBER OR OTHER DETAILS WERE PROVIDED. THE LABELING STATES THAT THE DEVICE IS NOT ABSORBABLE AND MUST BE REMOVED FROM WOUND PRIOR TO WOUND CLOSURE. THE LABELING FURTHER STATES THAT THE DEVICE MUST NOT REMAIN IN THE WOUND FOR LONGER THAN 24 HOURS. IN CONCLUSION THE PRODUCT FUNCTIONED PROPERLY AND STOPPED THE BLEEDING. THE DEVICE WAS LEFT IN THE WOUND DUE TO A USER ERROR. THE LABELING CLEARLY STATES THAT THE DEVICE CANNOT BE LEFT IN PLACE FOR MORE THAN 24 HOURS AND MUST BE REMOVED.

    Description of Event or Problem · 1

    A QUIKCLOT HEMOSTATIC DRESSING (EITHER QUIKCLOT 4X4 OR QUIKCLOT Z-FOLD) WAS USED DURING A SURGICAL ONCOLOGY / TRAUMA LAPAROTOMY PROCEDURE SOMETIME BETWEEN (B)(6) 2018. DURING A POST OPERATIVE X-RAY SCAN IT WAS NOTED THAT THE QUIKCLOT HEMOSTATIC DRESSING REMAINED INSIDE THE PATIENT. THE QUIKCLOT HEMOSTATIC DRESSING WAS REMOVED ON (B)(6) 2018. THE PATIENT IS IN STABLE CONDITION. THERE WERE NO PROBLEMS WITH THE USE OF THE QUIKCLOT HEMOSTATIC DRESSINGS. ALTHOUGH THIS INCIDENT WAS DIRECTLY RELATED TO USER ERROR AND NOT DIRECTLY RELATED TO THE DEVICE, THIS IS BEING REPORTED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53865 QUIKCLOT HEMOSTATIC DRESSING HEMOSTATIC WOUND DRESSING FRO Z-MEDICA, LLC UNKNOWN NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention