STYLE 68 SALINE FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-09388
- Event Type
- Injury
- Date Received
- June 6, 2025
- Date of Event
- April 1, 2025
- Report Date
- October 15, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FWM
- PMA / PMN Number
- P990074
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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: B5, D.6A, D.6B, H6.
LABORATORY ANALYSIS SUMMARY THE DEVICE RELATED TO THE REPORTED EVENTS DEFLATION AND PARTICLES IN VALVE WAS RECEIVED ON AUGUST 28, 2025, WITH LOT NUMBER 1820079. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ¿ DEFLATION: OBSERVED AN OPENING ASSESSED AS UNIDENTIFIED (TEAR) OPENING. ¿ PARTICLES IN VALVE: OBSERVED. AS PER THE INVESTIGATION PROCEDURE CREASES AND WEAR ABRASION WERE OBSERVED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.
HEALTHCARE PROFESSIONAL REPORTED "DEFLATION". THIS RECORD IS FOR THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
DEVICE WAS EXPLANTED AND REPLACED.
HEALTHCARE PROFESSIONAL LATER REPORTED "PARTICLES IN VALVE" OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1479926 | STYLE 68 SALINE FILLED BREAST IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN (COSTA RICA) | 1820079 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | Required Intervention |