FDA Adverse Event
Malfunction
Summary report: N
LIGHTRAIL REUSABLE FIBER
MDR report key: 4950426
·
Received July 27, 2015
Report
- Report Number
- 3006897895-2015-00005
- Event Type
- Malfunction
- Date Received
- July 27, 2015
- Date of Event
- June 19, 2015
- Report Date
- July 26, 2015
- Manufacturer
- STARMEDTEC GMBH
- Product Code
- GEX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 485536 | LIGHTRAIL REUSABLE FIBER | POWERED LASER SURGICAL INSTRUMENT | GEX | STARMEDTEC GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |