FDA Adverse Event
Malfunction
Summary report: N
NEXPOWDER
MDR report key: 20662050
·
Received November 12, 2024
Report
- Report Number
- 20662050
- Event Type
- Malfunction
- Date Received
- November 12, 2024
- Date of Event
- July 19, 2024
- Report Date
- October 3, 2024
- Manufacturer
- NEXTBIOMEDICAL CO., LTD.
- Product Code
- QAU
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
PER CLINICAL STAFF, PROVIDER ATTEMPTED TO USE NEXPOWDER HEMOSTASIS SYSTEM TWICE AND WAS UNABLE TO DEPLOY POWDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1059438 | NEXPOWDER | HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE | QAU | NEXTBIOMEDICAL CO., LTD. | CC24012511 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Unknown |