MAUDE manufacturer profile
COOK IRELAND LTD · FGE
MAUDE profile for Stents, Drains And Dilators For The Biliary Ducts
Key facts
| Manufacturer | COOK IRELAND LTD |
|---|---|
| Manufacturer group | COOK IRELAND LTD |
| Product code | FGE |
| Product code name | Stents, Drains And Dilators For The Biliary Ducts |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Improper or Incorrect Procedure or Method, No Known Impact Or Consequence To Patient, Off-Label Use, No Consequences Or Impact To Patient, Adverse Event Without Identified Device or Use Problem, Activation, Positioning or Separation Problem, Material Twisted/Bent 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