FDA Adverse Event
Injury
Summary report: N
STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
MDR report key: 3030268
·
Received March 28, 2013
Report
- Report Number
- 2024601-2013-00275
- Event Type
- Injury
- Date Received
- March 28, 2013
- Date of Event
- January 1, 2012
- Report Date
- February 27, 2013
- Manufacturer
- ALLERGAN
- Product Code
- FTR
- PMA / PMN Number
- P040046
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MEDWATCH SENT ON: (B)(4) 2013. DEVICE LABELING ((B)(4) STUDY) IS AS FOLLOWS: REVISION AUGMENTATION. RUPTURE: (B)(4). CAPSULAR CONTRACTURE: (B)(4).
Description of Event or Problem · 1
PHYSICIAN REPORTED EVENTS OF RIGHT DEVICE RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE IV WITH DEVICE REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 127514 | STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT | FTR | ALLERGAN | NA | 1125918 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention | NO INFORMATION |