MAUDE manufacturer profile
UNKNOWN MANUFACTURER · FWM
MAUDE profile for Prosthesis, Breast, Inflatable, Internal, Saline
Key facts
| Manufacturer | UNKNOWN MANUFACTURER |
|---|---|
| Manufacturer group | SANTA BARBARA |
| Product code | FWM |
| Product code name | Prosthesis, Breast, Inflatable, Internal, Saline |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 1,000+ Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Failure of Implant, Fluid/Blood Leak, Material Rupture, Capsular Contracture, Patient-Device Incompatibility, Adverse Event Without Identified Device or Use Problem, Seroma, Lymphoma 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