STYLE 68 SALINE FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2024-27010
- Event Type
- Injury
- Date Received
- December 31, 2024
- Report Date
- December 31, 2024
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FWM
- PMA / PMN Number
- P990074
- Adverse Event
- 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-CONFORMANCE'S 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 VALVE".
DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS DEFLATION RECEIVED ON SEP 24, 2025. WITH LOT NUMBER 2051088. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ¿ DEFLATION : OBSERVED AN OPENINGS ASSESSED AS SURGICAL DAMAGE AND ONE OPENING ASSESSED AS CRACKED VALVE SEAT DIAPHRAGM VALVE. AS PER THE INVESTIGATION PROCEDURE, CREASE 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 "RIGHT SIDE EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE". HEALTHCARE PROFESSIONAL LATER REPORTED "DEFLATION VALVE" PER DT FORM. THE DEVICE HAS BEEN EXPLANTED.
HEALTHCARE PROFESSIONAL REPORTED "RIGHT SIDE EXCHANGE WITH NO COMPLAINT AGAINST THE DEVICE". HEALTHCARE PROFESSIONAL LATER REPORTED "DEFLATION VALVE" PER DT FORM. THE DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1207472 | STYLE 68 SALINE FILLED BREAST IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN (COSTA RICA) | 2051088 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |