MAUDE manufacturer profile
ANGIODYNAMICS · OAB
MAUDE profile for Low Energy Direct Current Thermal Ablation System
Key facts
| Manufacturer | ANGIODYNAMICS |
|---|---|
| Manufacturer group | ANGIODYNAMICS |
| Product code | OAB |
| Product code name | Low Energy Direct Current Thermal Ablation System |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Fistula, Insufficient Information, Failure of Device to Self-Test, Communication or Transmission Problem, Arcing of Electrodes 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