MAUDE manufacturer profile
COOK INC · FGE
MAUDE profile for Stents, Drains And Dilators For The Biliary Ducts
Key facts
| Manufacturer | COOK INC |
|---|---|
| Manufacturer group | COOK INC |
| 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
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Difficult to Remove, Detachment of Device or Device Component, Material Separation, No Known Impact Or Consequence To Patient, Fluid/Blood Leak, No Code Available, Adverse Event Without Identified Device or Use Problem 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