MAUDE manufacturer profile
BOSTON SCIENTIFIC CORPORATION · FED
MAUDE profile for Endoscopic Access Overtube, Gastroenterology-Urology
Key facts
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC CORPORATION |
| Product code | FED |
| Product code name | Endoscopic Access Overtube, Gastroenterology-Urology |
At a glance
- 100–999 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, Material Split, Cut or Torn, Peeled/Delaminated, Material Integrity Problem, No Consequences Or Impact To Patient, Adverse Event Without Identified Device or Use Problem, Break, Perforation 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