MAUDE manufacturer profile
BOSTON SCIENTIFIC CORPORATION · KTI
MAUDE profile for Bronchoscope Accessory
Key facts
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC CORK LIMITED |
| Product code | KTI |
| Product code name | Bronchoscope Accessory |
At a glance
- 100–999 MAUDE reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Burst Container or Vessel, Leak/Splash, Material Puncture/Hole, Use of Device Problem, No Consequences Or Impact To Patient, Adverse Event Without Identified Device or Use Problem, Material Twisted/Bent 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