MAUDE manufacturer profile
AGA MEDICAL CORP. · MLV
MAUDE profile for Transcatheter Septal Occluder
Key facts
| Manufacturer | AGA MEDICAL CORP. |
|---|---|
| Manufacturer group | AGA MEDICAL CORPORATION |
| Product code | MLV |
| Product code name | Transcatheter Septal Occluder |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 1,000+ Injury reports
- 100–999 Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Material Deformation, No Consequences Or Impact To Patient, No Known Impact Or Consequence To Patient, Unintended Movement, Adverse Event Without Identified Device or Use Problem, Migration or Expulsion of Device, Pericardial Effusion, Embolism 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