MAUDE manufacturer profile
INVATEC SPA · FGE
MAUDE profile for Stents, Drains And Dilators For The Biliary Ducts
Key facts
| Manufacturer | INVATEC SPA |
|---|---|
| Manufacturer group | INVATEC SPA |
| Product code | FGE |
| Product code name | Stents, Drains And Dilators For The Biliary Ducts |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Device Dislodged or Dislocated, No Consequences Or Impact To Patient, Patient Problem/Medical Problem, Adverse Event Without Identified Device or Use Problem, Occlusion, Stenosis, Vascular Dissection, Material Deformation 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