FDA Adverse Event
Malfunction
Summary report: N
VERSAJET
MDR report key: 25315960
·
Received May 28, 2026
Report
- Report Number
- 25315960
- Event Type
- Malfunction
- Date Received
- May 28, 2026
- Date of Event
- May 15, 2026
- Report Date
- May 21, 2026
- Manufacturer
- SMITH NEPHEW MEDICAL LIMITED
- Product Code
- FQH
- UDI-DI
- 00040565124780
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TN
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
VERSAJET MACHINE FAULT LIGHT ERROR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 296428 | VERSAJET | LAVAGE, JET | FQH | SMITH NEPHEW MEDICAL LIMITED | 66800045 | 51329035 | 00040565124780 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Male | Other |