MAUDE manufacturer profile
W. L. GORE & ASSOCIATES, INC. · DYB
MAUDE profile for Introducer, Catheter
Key facts
| Manufacturer | W. L. GORE & ASSOCIATES, INC. |
|---|---|
| Manufacturer group | MEDICAL PHOENIX 1 B/P |
| Product code | DYB |
| Product code name | Introducer, Catheter |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 10–99 Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Vascular Dissection, Patient Device Interaction Problem, Adverse Event Without Identified Device or Use Problem, Perforation of Vessels, Patient-Device Incompatibility, Insufficient Information, Rupture, Aneurysm 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