STYLE 68 SALINE FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-07780
- Event Type
- Injury
- Date Received
- May 13, 2025
- Date of Event
- April 14, 2025
- Report Date
- July 14, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FWM
- UDI-DI
- 10888628000636
- PMA / PMN Number
- P990074
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
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.
DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS OF DEFLATION WAS RECEIVED ON JULY 15, 2025, WITH LOT NUMBER 3234015. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: ¿ DEFLATION: OBSERVED AN OPENING ASSESSED AS FOLD FLAW OPENING. 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.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, D6B, H6.
PATIENT REPORTED RIGHT SIDE "DEFLATION". HEALTHCARE PROFESSIONAL LATER CONFIRMED. DEVICE REMAINS IMPLANTED.
PATIENT REPORTED "DEFLATION". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2184958 | STYLE 68 SALINE FILLED BREAST IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN (COSTA RICA) | 3234015 | 10888628000636 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female | Required Intervention |