STYLE 115 SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-13506
- Event Type
- Injury
- Date Received
- August 10, 2025
- Date of Event
- May 27, 2025
- Report Date
- August 10, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT RUPTURE WAS RECEIVED ON AUGUST 27, 2025 WITH LOT NUMBER 2190032. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ¿ RUPTURE: OBSERVED AN OPENING ASSESSED AS FOLD FLAW OPENING AND TWO OPENINGS ASSESSED AS SURGICAL DAMAGE. AS PER THE INVESTIGATION PROCEDURE CREASES AND STRESS MARKS WERE OBSERVED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.
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: RUPTURE.
HEALTHCARE PROFESSIONAL REPORTED "REPLACEMENT DUE TO PROSTHESIS RUPTURED". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
HEALTHCARE PROFESSIONAL REPORTED "REPLACEMENT DUE TO PROSTHESIS RUPTURED". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2134843 | STYLE 115 SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2190032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Female | Required Intervention |