MAUDE manufacturer profile
INTEGRA YORK, PA INC. · FCW
MAUDE profile for Light Source, Fiberoptic, Routine
Key facts
| Manufacturer | INTEGRA YORK, PA INC. |
|---|---|
| Manufacturer group | INTEGRA YORK, PA INC. |
| Product code | FCW |
| Product code name | Light Source, Fiberoptic, Routine |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Consequences Or Impact To Patient, Overheating of Device, Smoking, Temperature Problem, No Clinical Signs, Symptoms or Conditions, Device Emits Odor, Melted 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