STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-00427
- Event Type
- Injury
- Date Received
- January 8, 2025
- Date of Event
- November 16, 2024
- Report Date
- May 27, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P040046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT DEFLATION/ ANXIETY/PRODUCT/PROCEDURE WAS RECEIVED ON (B)(6) 2025, WITH LOT NUMBER 3030555. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: RUPTURE: OBSERVED BROKEN DEVICE ASSESSED AS UNIDENTIFIED (TEAR) OPENING AS PER THE INVESTIGATION PROCEDURE CREASES WAS 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.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: H.6.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: H6. PHOTO EVALUATION: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: ¿ RUPTURE: OBSERVED RUPTURE ON THE DEVICE BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. NO ADDITIONAL OBSERVATIONS WERE CARRIED OUT. NO FURTHER ACTIONS ARE REQUIRED AS NO MANUFACTURING ISSUES ARE OBSERVED.
DISTRIBUTOR/COMMISSIONAIRE REPORTED "RUPTURE". THIS RECORD IS FOR RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.
DISTRIBUTOR/COMMISSIONAIRE REPORTED "RUPTURE". THIS RECORD IS FOR RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.
DISTRIBUTOR/COMMISSIONAIRE REPORTED "RUPTURE". THIS RECORD IS FOR RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.
DISTRIBUTOR/COMMISSIONAIRE REPORTED "RUPTURE". THIS RECORD IS FOR RIGHT SIDE. DEVICE WAS EXPLANTED AND REPLACED WITH A NON-ABBVIE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1536162 | STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 3030555 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female | Required Intervention |