MAUDE manufacturer profile
TERUMO BCT · GKT
MAUDE profile for Separator, Automated, Blood Cell, Diagnostic
Key facts
| Manufacturer | TERUMO BCT |
|---|---|
| Manufacturer group | TERUMO BCT |
| Product code | GKT |
| Product code name | Separator, Automated, Blood Cell, Diagnostic |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, No Patient Involvement, Insufficient Information, High Test Results, No Known Impact Or Consequence To Patient, No Apparent Adverse Event, High Readings 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