MAUDE manufacturer profile
W. L. GORE & ASSOCIATES, INC. · FGE
MAUDE profile for Stents, Drains And Dilators For The Biliary Ducts
Key facts
| Manufacturer | W. L. GORE & ASSOCIATES, INC. |
|---|---|
| Manufacturer group | MPD APC B/P |
| 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
- No Clinical Signs, Symptoms or Conditions, Difficult to Remove, No Known Impact Or Consequence To Patient, Fracture, Unraveled Material, Unspecified Hepatic or Biliary Problem, Migration or Expulsion of Device, Break 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