FDA Adverse Event Death Summary report: N

QUICKCLOT

MDR report key: 22921861 · Received August 29, 2025

Report

Report Number
MW5175399
Event Type
Death
Date Received
August 29, 2025
Date of Event
December 21, 2021
Report Date
February 11, 2022
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

(B)(6) 2021 PATIENT WITH EPISTAXIS AND RIGHT NARE PACKED WITH QUICKCLOT X3 SPRAYED WITH AFRIN. (B)(6) RN NOTES INDICATE NASAL PACKING REMOVED. (B)(6) 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. REFERENCE REPORTS: MW5107443, MW5107443-1 AND MW5175400.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2879266 QUICKCLOT HEMOSTATIC WOUND DRESSING WITHOUT THROMBIN OR OTHER BIOLOGICS QSY Z-MEDICA, LLC

Patients

Seq Age Sex Outcome Treatment
1 Male Death AFRIN NASAL SPRAY.