MAUDE manufacturer profile
BIOSENSE WEBSTER INC · MTD
MAUDE profile for Catheter, Intracardiac Mapping, High-Density Array
Key facts
| Manufacturer | BIOSENSE WEBSTER INC |
|---|---|
| Manufacturer group | BIOSENSE WEBSTER INC (JUAREZ) |
| Product code | MTD |
| Product code name | Catheter, Intracardiac Mapping, High-Density Array |
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, Obstruction of Flow, Patient Device Interaction Problem, Cardiac Tamponade, Entrapment of Device, No Consequences Or Impact To Patient, Detachment of Device or Device Component, Adverse Event Without Identified Device or Use Problem 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