MAUDE manufacturer profile
EDWARDS LIFESCIENCES, PR · DRS
MAUDE profile for Transducer, Blood-Pressure, Extravascular
Key facts
| Manufacturer | EDWARDS LIFESCIENCES, PR |
|---|---|
| Manufacturer group | EDWARDS LIFESCIENCES, PR |
| Product code | DRS |
| Product code name | Transducer, Blood-Pressure, Extravascular |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Break, No Clinical Signs, Symptoms or Conditions, Detachment of Device or Device Component, Hemorrhage/Blood Loss/Bleeding, Incorrect, Inadequate or Imprecise Result or Readings, Difficult to Remove 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