MAUDE manufacturer profile
BOSTON SCIENTIFIC CORPORATION · KOE
MAUDE profile for Dilator, Urethral
Key facts
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC IRELAND LIMITED |
| Product code | KOE |
| Product code name | Dilator, Urethral |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Material Puncture/Hole, No Consequences Or Impact To Patient, Burst Container or Vessel, Leak/Splash, Material Deformation, Device Contamination with Chemical or Other Material, Material Rupture 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