BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUIKCLOT

    MDR report key: 23165348 · Received September 29, 2025

    Report

    Report Number
    MW5176637
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    December 21, 2021
    Report Date
    August 8, 2025
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    QSY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2021 PATIENT WITH EPISTAXIS AND RIGHT NARE PACKED WITH QUICKCLOT X3 SPRAYED WITH AFRIN. ON (B)(6) 2021 REGISTERED NURSE NOTES INDICATE NASAL PACKING REMOVED. ON (B)(6) 2021 PATIENT DECOMPENSATES AND TRANSFERS TO INTENSIVE CARE UNIT. UNDERGOES FLEXIBLE FIBEROPTIC BRONCHOSCOPY WITH FINDINGS OF GAUZE-LIKE MATERIAL EXTENDING FROM LEFT BRONCHUS ABOVE LEVEL OF CARINA TO THE DISTAL TRACHEA. CRITICAL CARE NOTES INDICATE MULTIFACTORIAL CIRCULATORY SHOCK WITH HYPERCAPNIA RELATED TO AIRWAY OBSTRUCTION AND SEPTIC PNEUMONIA. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218714 QUIKCLOT HEMOSTATIC WOUND DRESSING WITHOUT THROMBIN OR OTHER BIOLOGICS QSY Z-MEDICA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown