MAUDE manufacturer profile
EDWARDS LIFESCIENCES PR · DYG
MAUDE profile for Catheter, Flow Directed
Key facts
| Manufacturer | EDWARDS LIFESCIENCES PR |
|---|---|
| Manufacturer group | EDWARDS LIFESCIENCES PR |
| Product code | DYG |
| Product code name | Catheter, Flow Directed |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 10–99 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Pacing Problem, No Known Impact Or Consequence To Patient, Incorrect Measurement, Incorrect, Inadequate or Imprecise Result or Readings, Material Rupture, Deflation 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