MAUDE manufacturer profile
W. L. GORE & ASSOCIATES, INC. · GXQ
MAUDE profile for Dura Substitute
Key facts
| Manufacturer | W. L. GORE & ASSOCIATES, INC. |
|---|---|
| Manufacturer group | MEDICAL PHOENIX 1 B/P |
| Product code | GXQ |
| Product code name | Dura Substitute |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Unspecified Infection, Abscess, Insufficient Information, Swelling, Patient Device Interaction Problem, Patient-Device Incompatibility, Migration or Expulsion of Device 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