MAUDE manufacturer profile
INTEGRA LIFESCIENCES (IRELAND) LTD. · FCW
MAUDE profile for Light Source, Fiberoptic, Routine
Key facts
| Manufacturer | INTEGRA LIFESCIENCES (IRELAND) LTD. |
|---|---|
| Manufacturer group | INTEGRA LIFESCIENCES (IRELAND) LTD. |
| Product code | FCW |
| Product code name | Light Source, Fiberoptic, Routine |
At a glance
- 100–999 MAUDE reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Overheating of Device, Circuit Failure, Smoking, Device Emits Odor, Failure to Power Up, Melted, Power Problem 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