FDA Adverse Event
Injury
Summary report: N
SILICONE GEL-FILLED BREAST IMPLANT, TX SHP RB
MDR report key: 2704036
·
Received July 25, 2012
Report
- Report Number
- 1651189-2012-00001
- Event Type
- Injury
- Date Received
- July 25, 2012
- Date of Event
- June 12, 2012
- Report Date
- July 16, 2012
- Manufacturer
- SIENTRA, INC
- Product Code
- FTR
- PMA / PMN Number
- P070004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
BILATERAL BREAST RECONSTRUCTION SURGERY PERFORMED ON (B)(6) 2012. ONE IMPLANT REMOVED AND REPLACED ON (B)(6) 2012 DUE TO SEROMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILICONE GEL-FILLED BREAST IMPLANT, TX SHP RB | FTR | SIENTRA, INC | 20646 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other |