MAUDE manufacturer profile
UROTRONIC, INC. · QRH
MAUDE profile for Catheter, Balloon, Urethral, Drug-Coated
Key facts
| Manufacturer | UROTRONIC, INC. |
|---|---|
| Manufacturer group | UROTRONIC, INC. |
| Product code | QRH |
| Product code name | Catheter, Balloon, Urethral, Drug-Coated |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Material Puncture/Hole, Defective Device, Material Rupture, Burning Sensation, Fistula, Numbness Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1