MAUDE manufacturer profile
EDWARDS LIFESCIENCES · DYE
MAUDE profile for Replacement Heart-Valve
Key facts
| Manufacturer | EDWARDS LIFESCIENCES |
|---|---|
| Manufacturer group | EDWARDS LIFESCIENCES |
| Product code | DYE |
| Product code name | Replacement Heart-Valve |
At a glance
- 1,000+ MAUDE reports
- 1,000+ Death reports
- 1,000+ Injury reports
- 100–999 Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Insufficient Information, Gradient Increase, Aortic Valve Stenosis, Degraded, Calcified, Heart Failure/Congestive Heart Failure, Dyspnea 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