FDA Adverse Event
Death
Summary report: N
QUICKCLOT
MDR report key: 22921880
·
Received August 29, 2025
Report
- Report Number
- MW5175400
- Event Type
- Death
- Date Received
- August 29, 2025
- Date of Event
- December 21, 2021
- Report Date
- February 11, 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
(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 MW5175399.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2880234 | QUICKCLOT | HEMOSTATIC WOUND DRESSING WITHOUT THROMBIN OR OTHER BIOLOGICS | QSY | Z-MEDICA, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male | Death | AFRIN NASAL SPRAY. |