FDA Adverse Event
Malfunction
Summary report: N
NATRELLE
MDR report key: 4143238
·
Received September 19, 2014
Report
- Report Number
- 4143238
- Event Type
- Malfunction
- Date Received
- September 19, 2014
- Date of Event
- April 22, 2014
- Report Date
- August 19, 2014
- Manufacturer
- ALLERGAN, INC.
- Product Code
- FWM
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 583356 | NATRELLE | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN, INC. | * | 1533316 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |