MAUDE manufacturer profile
ABBOTT MEDICAL · NKM
MAUDE profile for Mitral Valve Repair Devices
Key facts
| Manufacturer | ABBOTT MEDICAL |
|---|---|
| Manufacturer group | ABBOTT MEDICAL NORTHPOINT REG 3020950818 |
| 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 Clinical Signs, Symptoms or Conditions, Incomplete Coaptation, Mitral Valve Insufficiency/ Regurgitation, Unspecified Tissue Injury, Unintended Movement, Adverse Event Without Identified Device or Use Problem, Difficult to Open or Close, Difficult or Delayed Positioning 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