MAUDE manufacturer profile
EDWARDS LIFESCIENCES, PR · DQO
MAUDE profile for Catheter, Intravascular, Diagnostic
Key facts
| Manufacturer | EDWARDS LIFESCIENCES, PR |
|---|---|
| Manufacturer group | EDWARDS LIFESCIENCES, PR |
| Product code | DQO |
| Product code name | Catheter, Intravascular, Diagnostic |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, No Clinical Signs, Symptoms or Conditions, Material Puncture/Hole, Incorrect, Inadequate or Imprecise Result or Readings, Leak/Splash, Deflation Problem, Material Rupture, Failure to Deflate 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