MAUDE brand profile
ITREL II
MAUDE brand safety profile
Key facts
| Brand name | ITREL II |
|---|
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 100–999 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- Device Operates Differently Than Expected, No Known Impact Or Consequence To Patient, Pain, Therapeutic Effects, Unexpected, Adverse Event Without Identified Device or Use Problem, Insufficient Information, Electromagnetic Compatibility Problem, Complaint, Ill-Defined 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