MAUDE manufacturer profile
UNKNOWN MANUFACTURE · FWM
MAUDE profile for Prosthesis, Breast, Inflatable, Internal, Saline
Key facts
| Manufacturer | UNKNOWN MANUFACTURE |
|---|---|
| Manufacturer group | UNKNOWN MANUFACTURE |
| Product code | FWM |
| Product code name | Prosthesis, Breast, Inflatable, Internal, Saline |
At a glance
- 1–9 MAUDE reports
- 1–9 Injury reports
- 1–9 Problems flagged by Orca1 signal analytics
- Device Appears to Trigger Rejection, Adverse Event Without Identified Device or Use Problem, Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL), Capsular Contracture, Failure of Implant, No Apparent Adverse Event, Material Rupture, Fluid/Blood Leak 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