MAUDE manufacturer profile
EDWARDS LIFESCIENCES · LWQ
MAUDE profile for Heart-Valve, Mechanical
Key facts
| Manufacturer | EDWARDS LIFESCIENCES |
|---|---|
| Manufacturer group | EDWARDS LIFESCIENCES |
| Product code | LWQ |
| Product code name | Heart-Valve, Mechanical |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Insufficient Information, Appropriate Term/Code Not Available, Perivalvular Leak, No Information, Heart Failure/Congestive Heart Failure, Dyspnea, Adverse Event Without Identified Device or Use Problem 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