MAUDE manufacturer profile
UNKNOWN MANUFACTURER · FTR
MAUDE profile for Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
Key facts
| Manufacturer | UNKNOWN MANUFACTURER |
|---|---|
| Manufacturer group | UNKNOWN MANUFACTURER |
| Product code | FTR |
| Product code name | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 10–99 Problems flagged by Orca1 signal analytics
- Material Rupture, Failure of Implant, Capsular Contracture, Patient-Device Incompatibility, Seroma, Anaplastic Large Cell Lymphoma, Device Appears to Trigger Rejection, Adverse Event Without Identified Device or Use 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