MAUDE manufacturer profile
BIOSENSE WEBSTER INC · DRF
MAUDE profile for Catheter, Electrode Recording, Or Probe, Electrode Recording
Key facts
| Manufacturer | BIOSENSE WEBSTER INC |
|---|---|
| Manufacturer group | BIOSENSE WEBSTER INC (JUAREZ) |
| Product code | DRF |
| Product code name | Catheter, Electrode Recording, Or Probe, Electrode Recording |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Patient Device Interaction Problem, Cardiac Tamponade, Adverse Event Without Identified Device or Use Problem, No Consequences Or Impact To Patient, Entrapment of Device, Heart Block, Contamination /Decontamination 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