MAUDE brand profile
ASTRAL 100 EUR1
MAUDE brand safety profile
Key facts
| Brand name | ASTRAL 100 EUR1 |
|---|
At a glance
- 100–999 MAUDE reports
- 100–999 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Failure to Calibrate, No Clinical Signs, Symptoms or Conditions, Protective Measures Problem, Failure of Device to Self-Test, Battery Problem, Device Displays Incorrect Message, No Patient Involvement Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE brand safety profiles
Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1