MAUDE manufacturer profile
ENTELLUS MEDICAL, INC. · PNZ
MAUDE profile for Eustachian Tube Balloon Dilation Device
Key facts
| Manufacturer | ENTELLUS MEDICAL, INC. |
|---|---|
| Manufacturer group | ENTELLUS MEDICAL, INC. |
| Product code | PNZ |
| Product code name | Eustachian Tube Balloon Dilation Device |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, No Code Available, Inflammation, Patient Device Interaction Problem, Protective Measures Problem, Product Quality Problem, Hearing Impairment, Vascular Dissection 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