MAUDE manufacturer profile
BIOSENSE WEBSTER, INC. (JUAREZ) · LPB
MAUDE profile for Cardiac Ablation Percutaneous Catheter
Key facts
| Manufacturer | BIOSENSE WEBSTER, INC. (JUAREZ) |
|---|---|
| Manufacturer group | BIOSENSE WEBSTER, INC. (JUAREZ) |
| Product code | LPB |
| Product code name | Cardiac Ablation Percutaneous Catheter |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 100–999 Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Cardiac Tamponade, Adverse Event Without Identified Device or Use Problem, Low Blood Pressure/ Hypotension, Insufficient Information, Pericardial Effusion, No Known Impact Or Consequence To Patient, 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