MAUDE manufacturer profile
BIOSENSE WEBSTER, INC. (JUAREZ) · OAD
MAUDE profile for Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Key facts
| Manufacturer | BIOSENSE WEBSTER, INC. (JUAREZ) |
|---|---|
| Manufacturer group | BIOSENSE WEBSTER, INC. (JUAREZ) |
| Product code | OAD |
| Product code name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Cardiac Tamponade, Insufficient Information, No Known Impact Or Consequence To Patient, Low Blood Pressure/ Hypotension, Pericardial Effusion, No Consequences Or Impact To Patient, Device Operates Differently Than Expected 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