MAUDE manufacturer profile
SANTA BARBARA · FWM
MAUDE profile for Prosthesis, Breast, Inflatable, Internal, Saline
Key facts
| Manufacturer | SANTA BARBARA |
|---|---|
| Manufacturer group | SANTA BARBARA |
| Product code | FWM |
| Product code name | Prosthesis, Breast, Inflatable, Internal, Saline |
At a glance
- 100–999 MAUDE reports
- 100–999 Injury reports
- 10–99 Problems flagged by Orca1 signal analytics
- Failure of Implant, Material Rupture, Fluid/Blood Leak, Capsular Contracture, Device Appears to Trigger Rejection, Seroma, Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions 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