MAUDE manufacturer profile
HEART VALVES SANTA ANA · LWR
MAUDE profile for Heart-Valve, Non-Allograft Tissue
Key facts
| Manufacturer | HEART VALVES SANTA ANA |
|---|---|
| Manufacturer group | HEART VALVES SANTA ANA |
| Product code | LWR |
| Product code name | Heart-Valve, Non-Allograft Tissue |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Insufficient Information, No Information, Aortic Valve Stenosis, Adverse Event Without Identified Device or Use Problem, Aortic Regurgitation, Patient Device Interaction Problem, Endocarditis, Gradient Increase 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