MAUDE manufacturer profile
SORIN GROUP CANADA INC. · DYE
MAUDE profile for Replacement Heart-Valve
Key facts
| Manufacturer | SORIN GROUP CANADA INC. |
|---|---|
| Manufacturer group | SORIN GROUP CANADA INC. |
| Product code | DYE |
| Product code name | Replacement Heart-Valve |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Insufficient Information, Aortic Valve Stenosis, Calcified, No Code Available, Calcium Deposits/Calcification, No Information, Degraded, Death 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