MAUDE manufacturer profile
HAEMONETICS CORPORATION · GKT
MAUDE profile for Separator, Automated, Blood Cell, Diagnostic
Key facts
| Manufacturer | HAEMONETICS CORPORATION |
|---|---|
| Manufacturer group | HAEMONETICS CORPORATION |
| Product code | GKT |
| Product code name | Separator, Automated, Blood Cell, Diagnostic |
At a glance
- 100–999 MAUDE reports
- 100–999 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Device Operates Differently Than Expected, Temperature Problem, No Known Impact Or Consequence To Patient, Insufficient Information, Death, No Consequences Or Impact 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