STYLE 68 SALINE FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2024-19034
- Event Type
- Injury
- Date Received
- August 21, 2024
- Date of Event
- May 1, 2024
- Report Date
- November 19, 2024
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FWM
- PMA / PMN Number
- P990074
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT DEFLATION WAS RECEIVED ON DECEMBER 03, 2024. WITH LOT NUMBER 1033155. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ¿ DEFLATION: OBSERVED A CRACKED VALVE SEAT DIAPHRAGM VALVE. AS PER THE INVESTIGATION PROCEDURE, CREASES AND WEAR ABRASION WERE COMPLETED AND NONE OF THE OBSERVATIONS WERE 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/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: DEFLATION.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, B6, D6B, G2, H6.
PATIENT REPORTED "DEFLATION." HEALTHCARE PROFESSIONAL LATER CONFIRMED. THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.
PATIENT REPORTED, LEFT SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.
PATIENT REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2178985 | STYLE 68 SALINE FILLED BREAST IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN (COSTA RICA) | 1033155 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Required Intervention |