MAUDE manufacturer profile
ENVOY MEDICAL CORP. · OAF
MAUDE profile for Implant, Hearing, Active, Middle Ear, Totally Implanted
Key facts
| Manufacturer | ENVOY MEDICAL CORP. |
|---|---|
| Manufacturer group | ENVOY MEDICAL CORP. |
| Product code | OAF |
| Product code name | Implant, Hearing, Active, Middle Ear, Totally Implanted |
At a glance
- 100–999 MAUDE reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Wound Dehiscence, Hearing Impairment, Premature Discharge of Battery, Post Operative Wound Infection, Device Inoperable, Partial Hearing Loss, Incomplete or Inadequate Connection 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