MAUDE manufacturer profile
AV-TEMECULA-CT · NKM
MAUDE profile for Mitral Valve Repair Devices
Key facts
| Manufacturer | AV-TEMECULA-CT |
|---|---|
| Manufacturer group | MENLO PARK, CA REG# 3005070406 |
| Product code | NKM |
| Product code name | Mitral Valve Repair Devices |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Incomplete Coaptation, Mitral Regurgitation, Adverse Event Without Identified Device or Use Problem, Tissue Damage, Difficult to Remove, Difficult to Open or Close, Failure To Adhere Or Bond 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