MAUDE manufacturer profile
INTEGRA LIFESCIENCES MANSFIELD · GWM
MAUDE profile for Device, Monitoring, Intracranial Pressure
Key facts
| Manufacturer | INTEGRA LIFESCIENCES MANSFIELD |
|---|---|
| Manufacturer group | INTEGRA LIFESCIENCES MANSFIELD |
| Product code | GWM |
| Product code name | Device, Monitoring, Intracranial Pressure |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Insufficient Information, Incorrect, Inadequate or Imprecise Result or Readings, Output Problem, Display or Visual Feedback Problem, No Device Output, Fluid/Blood Leak, Incorrect Measurement 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