MAUDE manufacturer profile
RAUMEDIC AG · GWM
MAUDE profile for Device, Monitoring, Intracranial Pressure
Key facts
| Manufacturer | RAUMEDIC AG |
|---|---|
| Manufacturer group | RAUMEDIC AG |
| Product code | GWM |
| Product code name | Device, Monitoring, Intracranial Pressure |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Information, Use of Device Problem, Device Handling Problem, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Insufficient Information, No Consequences Or Impact To Patient, Unable to Obtain Readings 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