MAUDE manufacturer profile
INTEGRA NEUROSCICENCS IMPLANTS SA · GWM
MAUDE profile for Device, Monitoring, Intracranial Pressure
Key facts
| Manufacturer | INTEGRA NEUROSCICENCS IMPLANTS SA |
|---|---|
| Manufacturer group | INTEGRA NEUROSCICENCS IMPLANTS SA |
| Product code | GWM |
| Product code name | Device, Monitoring, Intracranial Pressure |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, No Known Impact Or Consequence To Patient, Injury, Incorrect, Inadequate or Imprecise Result or Readings, Device Operates Differently Than Expected, Break, Output Problem, Hematoma 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