MAUDE manufacturer profile
BOSTON SCIENTIFIC - GALWAY · FGE
MAUDE profile for Stents, Drains And Dilators For The Biliary Ducts
Key facts
| Manufacturer | BOSTON SCIENTIFIC - GALWAY |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC - GALWAY |
| 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
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Material Rupture, Difficult to Remove, Break, Activation, Positioning or Separation Problem, No Known Impact Or Consequence To Patient, Migration or Expulsion of Device, 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