MAUDE manufacturer profile
AV-TEMECULA-CT · LOX
MAUDE profile for Catheters, Transluminal Coronary Angioplasty, Percutaneous
Key facts
| Manufacturer | AV-TEMECULA-CT |
|---|---|
| Manufacturer group | EL COYOL, COSTA RICA REG# 3009031392 |
| Product code | LOX |
| Product code name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Material Rupture, Difficult to Remove, Detachment Of Device Component, Improper or Incorrect Procedure or Method, No Patient Involvement, Inflation Problem, Deflation Problem 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