MAUDE brand profile
EDWARDS AXELA INTRODUCER SET
MAUDE brand safety profile
Key facts
| Brand name | EDWARDS AXELA INTRODUCER SET |
|---|
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- Physical Resistance/Sticking, Vascular Dissection, Material Separation, Difficult to Remove, No Known Impact Or Consequence To Patient, Tissue Damage, Material Split, Cut or Torn, Adverse Event Without Identified Device or Use Problem 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