MAUDE brand profile
GENTLECATH
MAUDE brand safety profile
Key facts
| Brand name | GENTLECATH |
|---|
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
- Urinary Tract Infection, Adverse Event Without Identified Device or Use Problem, Hemorrhage/Blood Loss/Bleeding, Off-Label Use, Difficult to Remove, No Clinical Signs, Symptoms or Conditions, Device Misassembled During Manufacturing /Shipping, Device Handling 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