FDA Adverse Event
No answer provided
Summary report: N
VERSAJET
MDR report key: 16395951
·
Received February 17, 2023
Report
- Report Number
- 16395951
- Event Type
- No answer provided
- Date Received
- February 17, 2023
- Date of Event
- November 30, 2022
- Report Date
- February 10, 2023
- Manufacturer
- SMITH NEPHEW MEDICAL LIMITED
- Product Code
- FQH
- Report Source
- User Facility report
- Reporter Location
- MD
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
VERSAJET II HANDPIECE MAKING LOUND NOISE WHEN PEDAL IS PRESSED - SETTING AT 8 HOOKED TO SALINE AND UNCLAMPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 126141 | VERSAJET | LAVAGE, JET | FQH | SMITH NEPHEW MEDICAL LIMITED | 66800041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24820 DA | Male |