MAUDE manufacturer profile
IRRAS USA INC · GWM
MAUDE profile for Device, Monitoring, Intracranial Pressure
Key facts
| Manufacturer | IRRAS USA INC |
|---|---|
| Manufacturer group | IRRAS USA INC |
| Product code | GWM |
| Product code name | Device, Monitoring, Intracranial Pressure |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Break, Insufficient Information, Intracranial Pressure Increased, Output Problem, Brain Injury, Fluid/Blood Leak, Electrical /Electronic Property Problem, 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