MAUDE manufacturer profile
EDWARDS LIFESCIENCES LLC · NPU
MAUDE profile for Prosthesis, Mitral Valve, Percutaneously Delivered
Key facts
| Manufacturer | EDWARDS LIFESCIENCES LLC |
|---|---|
| Manufacturer group | EDWARDS LIFESCIENCES LLC |
| Product code | NPU |
| Product code name | Prosthesis, Mitral Valve, Percutaneously Delivered |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 100–999 Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Insufficient Information, Appropriate Term / Code Not Available, Perivalvular Leak, No Clinical Signs, Symptoms or Conditions, Injury, Malposition of Device 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