MAUDE manufacturer profile
EDWARDS LIFESCIENCES LLC · DYB
MAUDE profile for Introducer, Catheter
Key facts
| Manufacturer | EDWARDS LIFESCIENCES LLC |
|---|---|
| Manufacturer group | EDWARDS LIFESCIENCES LLC |
| Product code | DYB |
| Product code name | Introducer, Catheter |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Material Split, Cut or Torn, Physical Resistance/Sticking, Vascular Dissection, Peeled/Delaminated, Unspecified Vascular Problem, Material Puncture/Hole 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