MAUDE manufacturer profile
EDWARDS LIFESCIENCES · NKM
MAUDE profile for Mitral Valve Repair Devices
Key facts
| Manufacturer | EDWARDS LIFESCIENCES |
|---|---|
| Manufacturer group | EDWARDS LIFESCIENCES |
| Product code | NKM |
| Product code name | Mitral Valve Repair Devices |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Activation Failure, Tricuspid Valve Insufficiency/ Regurgitation, Mitral Valve Insufficiency/ Regurgitation, Patient Device Interaction Problem, Air Embolism, Air/Gas in Device, No Clinical Signs, Symptoms or Conditions, Cusp Tear 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