BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICKCLOT

    MDR report key: 13541526 · Received February 15, 2022

    Report

    Report Number
    MW5107443
    Event Type
    Death
    Date Received
    February 15, 2022
    Date of Event
    December 21, 2021
    Report Date
    August 29, 2025
    Manufacturer
    Z-MEDICA, LLC
    Product Code
    QSY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 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 MULTIFACTORIAL CIRCULATORY SHOCK WITH HYPERCAPNIA RELATED TO AIRWAY OBSTRUCTION AND SEPTIC PNA.

    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 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 MULTIFACTORIAL CIRCULATORY SHOCK WITH HYPERCAPNIA RELATED TO AIRWAY OBSTRUCTION AND SEPTIC PNA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472736 QUICKCLOT HEMOSTATIC WOUND DRESSING WITHOUT THROMBIN OR OTHER BIOLOGICS QSY Z-MEDICA, LLC
    473712 BLOOD STOP DRESSING, WOUND, DRUG QSY LIFESCIENCE PLUS, INC.
    473713 BLOOD STOP DRESSING, WOUND, DRUG QSY LIFESCIENCE PLUS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Death AFRIN NASAL SPRAY