MAUDE manufacturer profile
COOK IRELAND LTD · NIU
MAUDE profile for Stent, Superficial Femoral Artery, Drug-Eluting
Key facts
| Manufacturer | COOK IRELAND LTD |
|---|---|
| Manufacturer group | COOK IRELAND LTD |
| Product code | NIU |
| Product code name | Stent, Superficial Femoral Artery, Drug-Eluting |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 1,000+ Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Occlusion Within Device, Reocclusion, Adverse Event Without Identified Device or Use Problem, No Known Impact Or Consequence To Patient, Activation, Positioning or Separation Problem, No Consequences Or Impact To Patient, No Clinical Signs, Symptoms or Conditions, Fracture 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