MAUDE manufacturer profile
VOLCANO CORPORATION · OBJ
MAUDE profile for Catheter, Ultrasound, Intravascular
Key facts
| Manufacturer | VOLCANO CORPORATION |
|---|---|
| Manufacturer group | VOLCANO CORPORATION |
| Product code | OBJ |
| Product code name | Catheter, Ultrasound, Intravascular |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Material Separation, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Entrapment of Device, Adverse Event Without Identified Device or Use Problem, No Display/Image, Insufficient Information 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