MAUDE brand profile
ROTABLATOR
MAUDE brand safety profile
Key facts
| Brand name | ROTABLATOR |
|---|
At a glance
- 10–99 MAUDE reports
- 10–99 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 1–9 Problems coded
- 1–9 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Defective Device, No Consequences Or Impact To Patient, Failure to Advance, Application Interface Becomes Non-Functional Or Program Exits Abnormally, Output Problem, Mechanical Problem, Cardiac Arrest 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