MAUDE manufacturer profile
COOK INC · FED
MAUDE profile for Endoscopic Access Overtube, Gastroenterology-Urology
Key facts
| Manufacturer | COOK INC |
|---|---|
| Manufacturer group | COOK INC |
| Product code | FED |
| Product code name | Endoscopic Access Overtube, Gastroenterology-Urology |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Peeled/Delaminated, Unsealed Device Packaging, Difficult to Advance, Flaked, Insufficient Information, Material Separation, Foreign Body In Patient 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