FDA Adverse Event
Injury
Summary report: N
STYLE 10 SILICONE GEL FILLED BREAST IMPLANT
MDR report key: 3031016
·
Received November 15, 2012
Report
- Report Number
- 2024601-2012-01255
- Event Type
- Injury
- Date Received
- November 15, 2012
- Date of Event
- December 16, 2009
- Report Date
- June 4, 2010
- Manufacturer
- ALLERGAN
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MED WATCH SUBMITTED ON (B)(4) 2012. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF SEROMA AS FOLLOWS: THE (B)(4) STUDY: 7 YEAR ADVERSE EVENT RATES: FOR PRIMARY AUGMENTATION PATIENTS, SEROMA RATE = (B)(4). PRIMARY RECONSTRUCTION PATIENTS, SEROMA RATE = (B)(4). SWELLING = (B)(4). "AFTER BREAST IMPLANT SURGERY THE FOLLOWING MAY OCCUR AND/OR PERSIST, WITH VARYING INTENSITY AND/OR FOR A VARYING LENGTH OF TIME: HEMATOMA/SEROMA." (ALLERGAN SILICONE LABELING). DEVICE LABELING REVIEWED: THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL, FOR PATIENTS IN THE (B)(4) STUDY, IN THE LABELING FOR SILICONE IMPLANTS.
Description of Event or Problem · 1
HEALTH PROFESSIONAL REPORTED LEFT SIDE PAIN, ACCUMULATION OF FLUID AND DIAGNOSIS OF ALCL. THIS EVENT WAS REPORTED VIA EPSR Q2 (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STYLE 10 SILICONE GEL FILLED BREAST IMPLANT | FTR | ALLERGAN | NA | 1361759 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention | BRONCHITIS| HISTORY |