MAUDE brand profile
ENTERPRISE 8000
MAUDE brand safety profile
Key facts
| Brand name | ENTERPRISE 8000 |
|---|
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Unintended Movement, No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Detachment of Device or Device Component, No Patient Involvement, Fracture, Fall 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