MAUDE manufacturer profile
OTICON MEDICAL AB · PFO
MAUDE profile for Active Implantable Bone Conduction Hearing System
Key facts
| Manufacturer | OTICON MEDICAL AB |
|---|---|
| Manufacturer group | OTICON MEDICAL AB |
| Product code | PFO |
| Product code name | Active Implantable Bone Conduction Hearing System |
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, Wound Dehiscence, Post Operative Wound Infection, Appropriate Term / Code Not Available, Patient Device Interaction Problem, Necrosis, Compatibility Problem, Skin Infection 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