MAUDE manufacturer profile
EDWARDS LIFESCIENCES · NPV
MAUDE profile for Pulmonary Valve Prosthesis Percutaneously Delivered
Key facts
| Manufacturer | EDWARDS LIFESCIENCES |
|---|---|
| Manufacturer group | EDWARDS LIFESCIENCES |
| Product code | NPV |
| Product code name | Pulmonary Valve Prosthesis Percutaneously Delivered |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Insufficient Information, No Clinical Signs, Symptoms or Conditions, Fluid/Blood Leak, Adverse Event Without Identified Device or Use Problem, Fracture, Degraded, Malposition of Device, Perivalvular 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