MAUDE manufacturer profile
BIOSENSE WEBSTER INC · OBJ
MAUDE profile for Catheter, Ultrasound, Intravascular
Key facts
| Manufacturer | BIOSENSE WEBSTER INC |
|---|---|
| Manufacturer group | SIEMENS LTD. SEOUL |
| Product code | OBJ |
| Product code name | Catheter, Ultrasound, Intravascular |
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
- No Clinical Signs, Symptoms or Conditions, Patient Device Interaction Problem, Cardiac Tamponade, Contamination /Decontamination Problem, Adverse Event Without Identified Device or Use Problem, No Display/Image, No Known Impact Or Consequence To Patient, No Consequences Or Impact To Patient 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