MAUDE manufacturer profile
COOK INC · GCA
MAUDE profile for Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Key facts
| Manufacturer | COOK INC |
|---|---|
| Manufacturer group | COOK INC |
| Product code | GCA |
| Product code name | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Code Available, Difficult to Remove, Leak/Splash, No Consequences Or Impact To Patient, Material Separation, Break, Fluid/Blood Leak 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