MAUDE manufacturer profile
COOK INC · FAP
MAUDE profile for Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Key facts
| Manufacturer | COOK INC |
|---|---|
| Manufacturer group | COOK INC |
| Product code | FAP |
| Product code name | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device |
At a glance
- 1–9 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- Device Contaminated During Manufacture or Shipping, No Clinical Signs, Symptoms or Conditions, Material Rupture, Fluid/Blood Leak, Foreign Body In Patient, No Patient Involvement, Insufficient Information, No Known Impact Or Consequence To 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