MAUDE manufacturer profile
EDWARDS LIFESCIENCES · DWF
MAUDE profile for Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Key facts
| Manufacturer | EDWARDS LIFESCIENCES |
|---|---|
| Manufacturer group | EDWARDS LIFESCIENCES LLC |
| Product code | DWF |
| Product code name | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Fluid/Blood Leak, Perforation, Break, Material Separation, Hemorrhage/Blood Loss/Bleeding 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