MAUDE manufacturer profile
EDWARDS LIFESCIENCES LLC · LWR
MAUDE profile for Heart-Valve, Non-Allograft Tissue
Key facts
| Manufacturer | EDWARDS LIFESCIENCES LLC |
|---|---|
| Manufacturer group | EDWARDS LIFESCIENCES LLC |
| Product code | LWR |
| Product code name | Heart-Valve, Non-Allograft Tissue |
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
- Insufficient Information, Adverse Event Without Identified Device or Use Problem, Heart Failure/Congestive Heart Failure, Perivalvular Leak, Gradient Increase, Dyspnea, Fluid/Blood Leak 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