MAUDE manufacturer profile
FENWAL INTERNATIONAL INC. · GKT
MAUDE profile for Separator, Automated, Blood Cell, Diagnostic
Key facts
| Manufacturer | FENWAL INTERNATIONAL INC. |
|---|---|
| Manufacturer group | FENWAL INTERNATIONAL INC. |
| Product code | GKT |
| Product code name | Separator, Automated, Blood Cell, Diagnostic |
At a glance
- 10–99 MAUDE reports
- 10–99 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Appropriate Term/Code Not Available, Patient Problem/Medical Problem, Adverse Event Without Identified Device or Use Problem, Appropriate Term / Code Not Available, Sepsis, Hematuria, Fluid/Blood Leak, No Clinical Signs, Symptoms or Conditions 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