MAUDE manufacturer profile
GYRUS ACMI, INC. · OAZ
MAUDE profile for One-Way Air-Leak Valve
Key facts
| Manufacturer | GYRUS ACMI, INC. |
|---|---|
| Manufacturer group | GYRUS ACMI, INC. |
| Product code | OAZ |
| Product code name | One-Way Air-Leak Valve |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Pneumonia, Adverse Event Without Identified Device or Use Problem, Migration, Off-Label Use, Pneumothorax, Hypoxia, Gas/Air Leak, Appropriate Term / Code Not Available 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