MAUDE manufacturer profile
SYSMEX AMERICA INC. · OUG
MAUDE profile for Medical Device Data System
Key facts
| Manufacturer | SYSMEX AMERICA INC. |
|---|---|
| Manufacturer group | SYSMEX AMERICA INC. |
| Product code | OUG |
| Product code name | Medical Device Data System |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Device Operates Differently Than Expected, Computer Software Problem, Adverse Event Without Identified Device or Use Problem, Application Program Problem: Parameter Calculation Error, No Clinical Signs, Symptoms or Conditions, Fire, Low Test Results 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