MAUDE manufacturer profile
COOK ENDOSCOPY · FGE
MAUDE profile for Stents, Drains And Dilators For The Biliary Ducts
Key facts
| Manufacturer | COOK ENDOSCOPY |
|---|---|
| Manufacturer group | COOK ENDOSCOPY |
| Product code | FGE |
| Product code name | Stents, Drains And Dilators For The Biliary Ducts |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Off-Label Use, Use of Device Problem, Foreign Body In Patient, Hole In Material, Leak/Splash, Migration or Expulsion of Device, Material Puncture/Hole 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