MAUDE manufacturer profile
TRIMEDYNE, INC. · GEX
MAUDE profile for Powered Laser Surgical Instrument
Key facts
| Manufacturer | TRIMEDYNE, INC. |
|---|---|
| Manufacturer group | TRIMEDYNE, INC. |
| Product code | GEX |
| Product code name | Powered Laser Surgical Instrument |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Overheating of Device, Material Separation, Melted, Material Discolored, Thermal Decomposition of Device, Use of Device Problem, Device Issue 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