MAUDE manufacturer profile
LUTONIX, INC · PRC
MAUDE profile for Drug-Coated Peripheral Transluminal Angioplasty Catheter
Key facts
| Manufacturer | LUTONIX, INC |
|---|---|
| Manufacturer group | C.R. BARD, INC. (GFO) |
| Product code | PRC |
| Product code name | Drug-Coated Peripheral Transluminal Angioplasty Catheter |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Restenosis, No Clinical Signs, Symptoms or Conditions, Thrombosis/Thrombus, Hemorrhage/Blood Loss/Bleeding, Material Rupture, Aneurysm, 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