MAUDE manufacturer profile
GYRUS ACMI, INC. · ERL
MAUDE profile for Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Key facts
| Manufacturer | GYRUS ACMI, INC. |
|---|---|
| Manufacturer group | GYRUS ACMI, INC. |
| Product code | ERL |
| Product code name | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Defective Device, No Patient Involvement, Output Problem, No Consequences Or Impact To Patient, Overheating of Device, Leak/Splash, Adverse Event Without Identified Device or Use 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