MAUDE manufacturer profile
BIOSENSE WEBSTER INC · LDF
MAUDE profile for Electrode, Pacemaker, Temporary
Key facts
| Manufacturer | BIOSENSE WEBSTER INC |
|---|---|
| Manufacturer group | BIOSENSE WEBSTER INC (JUAREZ) |
| Product code | LDF |
| Product code name | Electrode, Pacemaker, Temporary |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Cardiac Tamponade, Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Patient Device Interaction Problem, Break, No Code Available, Material Twisted/Bent, Material Protrusion/Extrusion 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