MAUDE manufacturer profile
MPRI · OAE
MAUDE profile for Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Key facts
| Manufacturer | MPRI |
|---|---|
| Manufacturer group | MPRI |
| Product code | OAE |
| Product code name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Material Twisted/Bent, Adverse Event Without Identified Device or Use Problem, Protective Measures Problem, Material Integrity Problem, Excessive Cooling, Device Contamination with Body Fluid, Pericardial Effusion 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