MAUDE manufacturer profile
ABBOTT MEDICAL · LWR
MAUDE profile for Heart-Valve, Non-Allograft Tissue
Key facts
| Manufacturer | ABBOTT MEDICAL |
|---|---|
| Manufacturer group | ST. JUDE MEDICAL LTDA. REG#3001883144 |
| Product code | LWR |
| Product code name | Heart-Valve, Non-Allograft Tissue |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Aortic Valve Insufficiency/ Regurgitation, Device Stenosis, Intravalvular regurgitation, Aortic Valve Stenosis, Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Dyspnea, Material Split, Cut or Torn 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