MAUDE manufacturer profile
COOK INC · KOE
MAUDE profile for Dilator, Urethral
Key facts
| Manufacturer | COOK INC |
|---|---|
| Manufacturer group | COOK INC |
| Product code | KOE |
| Product code name | Dilator, Urethral |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, No Clinical Signs, Symptoms or Conditions, Device Contamination with Chemical or Other Material, Peeled/Delaminated, No Patient Involvement, Foreign Body In Patient, No Code Available, Device Contaminated During Manufacture or Shipping 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