MAUDE manufacturer profile
COOK ENDOSCOPY · QAU
MAUDE profile for Hemostatic Device For Endoscopic Gastrointestinal Use
Key facts
| Manufacturer | COOK ENDOSCOPY |
|---|---|
| Manufacturer group | COOK ENDOSCOPY |
| Product code | QAU |
| Product code name | Hemostatic Device For Endoscopic Gastrointestinal Use |
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 Consequences Or Impact To Patient, Failure to Fire, Activation Failure, No Clinical Signs, Symptoms or Conditions, Obstruction of Flow, Complete Blockage, No Patient Involvement, Improper or Incorrect Procedure or Method 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