MAUDE manufacturer profile
AV-TEMECULA-CT · MAF
MAUDE profile for Stent, Coronary
Key facts
| Manufacturer | AV-TEMECULA-CT |
|---|---|
| Manufacturer group | CLONMEL, IRELAND REG# 9616693 |
| Product code | MAF |
| Product code name | Stent, Coronary |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Failure to Advance, Improper or Incorrect Procedure or Method, Device Operates Differently Than Expected, Death, Adverse Event Without Identified Device or Use Problem, Device Dislodged or Dislocated, 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