MAUDE manufacturer profile
CANDELA CORPORATION · GEX
MAUDE profile for Powered Laser Surgical Instrument
Key facts
| Manufacturer | CANDELA CORPORATION |
|---|---|
| Manufacturer group | CANDELA CORPORATION |
| Product code | GEX |
| Product code name | Powered Laser Surgical Instrument |
At a glance
- 100–999 MAUDE reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Device Operational Issue, Radiation Exposure, Unintended, Adverse Event Without Identified Device or Use Problem, Burn(s), Insufficient Information, Partial thickness (Second Degree) Burn, Improper or Incorrect Procedure or Method, Injury 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