MAUDE manufacturer profile
FOTONA D.O.O. · GEX
MAUDE profile for Powered Laser Surgical Instrument
Key facts
| Manufacturer | FOTONA D.O.O. |
|---|---|
| Manufacturer group | Fotona d.o.o. |
| Product code | GEX |
| Product code name | Powered Laser Surgical Instrument |
At a glance
- 1–9 MAUDE reports
- 1–9 Injury reports
- 10–99 Problems flagged by Orca1 signal analytics
- Lack of Effect, Device Handling Problem, Use of Device Problem, Patient Device Interaction Problem, Insufficient Information, Adverse Event Without Identified Device or Use Problem, Decreased Sensitivity, Apnea Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1