MAUDE manufacturer profile
AGA MEDICAL CORPORATION · MAE
MAUDE profile for Occluder, Patent Ductus, Arteriosus
Key facts
| Manufacturer | AGA MEDICAL CORPORATION |
|---|---|
| Manufacturer group | AGA MEDICAL CORPORATION |
| Product code | MAE |
| Product code name | Occluder, Patent Ductus, Arteriosus |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Migration or Expulsion of Device, No Consequences Or Impact To Patient, Embolism, No Known Impact Or Consequence To Patient, Unintended Movement, Material Deformation, Improper or Incorrect Procedure or Method, Obstruction/Occlusion 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