MAUDE manufacturer profile
W. L. GORE & ASSOCIATES, INC. · DXZ
MAUDE profile for Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Key facts
| Manufacturer | W. L. GORE & ASSOCIATES, INC. |
|---|---|
| Manufacturer group | MEDICAL PHOENIX 1 B/P |
| Product code | DXZ |
| Product code name | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Insufficient Information, Adhesion(s), Adverse Event Without Identified Device or Use Problem, Off-Label Use, No Clinical Signs, Symptoms or Conditions, Pulmonary Valve Insufficiency/ Regurgitation, Patient-Device Incompatibility, Patient Device Interaction Problem 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