MAUDE brand profile
TENKU DILATATION CATHETER
MAUDE brand safety profile
Key facts
| Brand name | TENKU DILATATION CATHETER |
|---|
At a glance
- 100–999 MAUDE reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Material Rupture, Physical Resistance, Improper or Incorrect Procedure or Method, Difficult to Remove, Failure to Advance, Detachment Of Device Component, Inflation 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