MAUDE brand profile
WATCHMAN ACCESS SYSTEM
MAUDE brand safety profile
Key facts
| Brand name | WATCHMAN ACCESS SYSTEM |
|---|
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 1,000+ Injury reports
- 100–999 Malfunction reports
- 100–999 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Pericardial Effusion, No Consequences Or Impact To Patient, Material Deformation, No Clinical Signs, Symptoms or Conditions, Low Blood Pressure/ Hypotension, Cardiac Tamponade, Difficult to Remove 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