STYLE 168 SALINE FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-02189
- Event Type
- Injury
- Date Received
- February 8, 2025
- Date of Event
- January 25, 2025
- Report Date
- August 6, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FWM
- PMA / PMN Number
- P990074
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: DEFLATION.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9, H3, H6. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF DEFLATION WAS RECEIVED ON AUGUST 07, 2025, WITH LOT NUMBER 3120998. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: DEFLATION: OBSERVED AN OPENING ASSESSED AS SURGICAL IMPACT OPENING. AS PER THE INVESTIGATION PROCEDURES, CREASES AND NON-PENETRATING NICKS WERE COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A6, B5, D6B, H6.
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT-SIDE. DEVICE HAS BEEN EXPLANTED.
DEVICE HAS BEEN EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 867270 | STYLE 168 SALINE FILLED BREAST IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN (COSTA RICA) | 3120998 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Female | Required Intervention |