MAUDE brand profile
SINGLE USE 3LUMEN SPHINCTEROTOME
MAUDE brand safety profile
Key facts
| Brand name | SINGLE USE 3LUMEN SPHINCTEROTOME |
|---|
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- Break, No Consequences Or Impact To Patient, Hemorrhage/Blood Loss/Bleeding, Thermal Decomposition of Device, Bowel Burn, Adverse Event Without Identified Device or Use Problem, Device Handling Problem, Perforation 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