MAUDE manufacturer profile
BOSTON SCIENTIFIC CORPORATION · GBA
MAUDE profile for Catheter, Balloon Type
Key facts
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC CORK LIMITED |
| Product code | GBA |
| Product code name | Catheter, Balloon Type |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- Display or Visual Feedback Problem, No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Adverse Event Without Identified Device or Use Problem, Incorrect Measurement, Inflation Problem, No Known Impact Or Consequence To Patient, Positioning 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