MAUDE manufacturer profile
SYSMEX CORPORATION, I SQUARE · JPA
MAUDE profile for System, Multipurpose For In Vitro Coagulation Studies
Key facts
| Manufacturer | SYSMEX CORPORATION, I SQUARE |
|---|---|
| Manufacturer group | SYSMEX CORPORATION, I SQUARE |
| Product code | JPA |
| Product code name | System, Multipurpose For In Vitro Coagulation Studies |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Use of Device Problem, No Consequences Or Impact To Patient, No Clinical Signs, Symptoms or Conditions, Overheating of Device, Leak/Splash, Improper or Incorrect Procedure or Method, Exposure to Body Fluids 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