MAUDE manufacturer profile
EDWARDS LIFSCIENCES · LWR
MAUDE profile for Heart-Valve, Non-Allograft Tissue
Key facts
| Manufacturer | EDWARDS LIFSCIENCES |
|---|---|
| Manufacturer group | EDWARDS LIFESCIENCES |
| Product code | LWR |
| Product code name | Heart-Valve, Non-Allograft Tissue |
At a glance
- 1–9 MAUDE reports
- 1–9 Injury reports
- 1–9 Problems flagged by Orca1 signal analytics
- Fluid/Blood Leak, Adverse Event Without Identified Device or Use Problem, Endocarditis 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