BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUIKCLOT HEMOSTATIC DRESSING, 4X4, 10X

    MDR report key: 22868989 · Received August 21, 2025

    Report

    Report Number
    3004138549-2025-00005
    Event Type
    Death
    Date Received
    August 21, 2025
    Date of Event
    December 21, 2021
    Report Date
    August 6, 2025
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    QSY
    PMA / PMN Number
    K123387
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT RECIEVED VIA MEDWATCH REPORT #MW5107443. PLEASE NOTE THAT 3 DEVICES WERE REPORTED, NOT 3 SEPARATE EVENTS. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS NO LOT NUMBER WAS REPORTED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4). QUIKCLOT PRODUCTS ARE INTENDED FOR USE AS TOPICAL DRESSINGS. THE COMPLAINANT REPORTED THAT THE NASAL PACKING (GAUZE) WAS REMOVED, IN DICATING THAT THE GAUZE-LIKE MATERIAL OBSERVED DURING BRONCHOSCOPY WAS NOT QUIKCLOT PRODUCT. ELONGATION AND TENSILE STRENGTH TESTING IS CONDUCTED ON EACH LOT OF GAUZE USED IN QUIKCLOT PRODUCTS. THIS TESTING ENSURES THAT GAUZE INTEGRITY IS MAINTAINED, WITH NO OPPOR TUNITY FOR THE GAUZE TO SEPARATE OR FRAGMENT WHEN USED IN ACCORDANCE WITH THE SUPPLIED IFU. THIS ELIMINATES THE POSSIBILITY THAT GAUZE MAY HAVE SEPARATED DURING THE REPORTED REMOVAL. THE IFU CLEARLY STATES IN THE WARNINGS SECTION: 1) PRODUCT IS NOT ABSORBABLE AND MUST BE REMOVED FROM THE WOUND PRIOR TO WOUND CLOSURE. 2) THE QUIKCLOT HEMOSTATIC DRESSING MUST NOT REMAIN IN THE WOUND FOR LONGER THAN 24 HOURS. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED, AS A LOT NUMBER WAS NOT REPORTED. THIS COMPLAINT IS CONSIDERED THE RESULT OF USER ERROR, NOT LIKELY ASSOCIATED WITH THE QUIKCLOT PRODUCT, AND POSSIBLY THE DIRECT RESULT OF NOT ADHERING TO IFU INSTRUCTIONS AND WARNINGS. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Description of Event or Problem · 0

    REPORTED VIA A MEDWATCH REPORT, THE REPORTER STATES "ON (B)(6) 2021 PATIENT WITH EPISTAXIS ANO RIGHT NARE PACKED WITH QUICKCLOT X3 SPRAYED WITH AFRIN. ON (B)(6) 2021 RN NOTES INDICATE NASAL PACKING REMOVED. ON (B)(6) 2021 PATIENT DECOMPENSATES AND TRANSFERS TO ICU. 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 MUL TL FACTORIAL CIRCULATORY SHOCK WITH HYPERCAPNIA RELATED TO AIRWAY OBSTRUCTION AND SEPTIC PNA". THE REPORT STATES THAT THE PATIENT CONDITION IS "DECEASED".

    Description of Event or Problem · 0

    REPORTED VIA A MEDWATCH REPORT, THE REPORTER STATES "ON (B)(6) 2021 PATIENT WITH EPISTAXIS ANO RIGHT NARE PACKED WITH QUICKCLOT X3 SPRAYED WITH AFRIN. ON (B)(6) 2021 RN NOTES INDICATE NASAL PACKING REMOVED. ON (B)(6) 2021 PATIENT DECOMPENSATES AND TRANSFERS TO ICU. 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 MULTI-FACTORIAL CIRCULATORY SHOCK WITH HYPERCAPNIA RELATED TO AIRWAY OBSTRUCTION AND SEPTIC PNA". THE REPORT STATES THAT THE PATIENT CONDITION IS "DECEASED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192818 QUIKCLOT HEMOSTATIC DRESSING, 4X4, 10X DRESSING, WOUND, DRUG QSY Z-MEDICA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death N/A.| N/A.