MAUDE manufacturer profile
INTERSECT ENT INC. · OWO
MAUDE profile for Drug-Eluting Sinus Stent
Key facts
| Manufacturer | INTERSECT ENT INC. |
|---|---|
| Manufacturer group | INTERSECT ENT INC. |
| Product code | OWO |
| Product code name | Drug-Eluting Sinus Stent |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Unspecified Infection, Migration or Expulsion of Device, Cerebrospinal Fluid Leakage, Pain, Choking, Foreign Body Reaction, Headache 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