MAUDE manufacturer profile
COCHLEAR LTD · PFO
MAUDE profile for Active Implantable Bone Conduction Hearing System
Key facts
| Manufacturer | COCHLEAR LTD |
|---|---|
| Manufacturer group | COCHLEAR LTD |
| Product code | PFO |
| Product code name | Active Implantable Bone Conduction Hearing System |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 1,000+ Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Appropriate Term/Code Not Available, Unspecified Infection, Expulsion, Tissue Breakdown, Appropriate Term / Code Not Available, Wound Dehiscence, Adverse Event Without Identified Device or Use Problem, Pain 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