MAUDE manufacturer profile
EDWARDS LIFESCIENCES PR · DQE
MAUDE profile for Catheter, Oximeter, Fiber-Optic
Key facts
| Manufacturer | EDWARDS LIFESCIENCES PR |
|---|---|
| Manufacturer group | EDWARDS LIFESCIENCES PR |
| Product code | DQE |
| Product code name | Catheter, Oximeter, Fiber-Optic |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, No Clinical Signs, Symptoms or Conditions, Incorrect, Inadequate or Imprecise Result or Readings, No Known Impact Or Consequence To Patient, Material Rupture, Incorrect Measurement, Leak/Splash, Adverse Event Without Identified Device or Use 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