MAUDE manufacturer profile
INTEGRA LIFESCIENCES(IRELAND) · GWM
MAUDE profile for Device, Monitoring, Intracranial Pressure
Key facts
| Manufacturer | INTEGRA LIFESCIENCES(IRELAND) |
|---|---|
| Manufacturer group | INTEGRA LIFESCIENCES(IRELAND) |
| Product code | GWM |
| Product code name | Device, Monitoring, Intracranial Pressure |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Device Operates Differently Than Expected, No Consequences Or Impact To Patient, No Patient Involvement, Device Displays Incorrect Message, Failure to Power Up, Incorrect, Inadequate or Imprecise Result or Readings, Defective Device 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