MAUDE manufacturer profile
SORIN GROUP ITALIA SRL · LWQ
MAUDE profile for Heart-Valve, Mechanical
Key facts
| Manufacturer | SORIN GROUP ITALIA SRL |
|---|---|
| Manufacturer group | SORIN GROUP ITALIA SRL |
| Product code | LWQ |
| Product code name | Heart-Valve, Mechanical |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Insufficient Information, No Information, Adverse Event Without Identified Device or Use Problem, Difficult to Open or Close, Endocarditis, Death, No Known Impact Or Consequence To Patient, Aortic Valve Stenosis 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