MAUDE manufacturer profile
BOSTON SCIENTIFIC CORPORATION · FDT
MAUDE profile for Duodenoscope And Accessories, Flexible/Rigid
Key facts
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC CORPORATION |
| Product code | FDT |
| Product code name | Duodenoscope And Accessories, Flexible/Rigid |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Optical Problem, Poor Quality Image, Adverse Event Without Identified Device or Use Problem, Burst Container or Vessel, Material Puncture/Hole, Material Too Rigid or Stiff, No Consequences Or Impact To Patient 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