MAUDE brand profile
PACKAGE500PPP03INTL EN500BASUK10
MAUDE brand safety profile
Key facts
| Brand name | PACKAGE500PPP03INTL EN500BASUK10 |
|---|
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, No Patient Involvement, Defective Device, Audible Prompt/Feedback Problem, Electrical /Electronic Property Problem, Failure to Power Up, Key or Button Unresponsive/not Working, Failure to Sense 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