STYLE 110 SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-00976
- Event Type
- Injury
- Date Received
- January 16, 2025
- Date of Event
- December 9, 2024
- Report Date
- May 16, 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
- 003
Narratives
LABORATORY ANALYSIS SUMMARY: THE DEVICE RELATED TO THE REPORTED EVENTS RUPTURE AND SEROMA-LATE WAS RECEIVED ON APRIL 01, 2025, WITH LOT NUMBER 2231691. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: RUPTURE: OBSERVED A BROKEN ASSESSED AS AN UNIDENTIFIED (TEAR) OPENING (SHELL THICKNESS WITHIN SPEC) AND OBSERVED MISSING SHELL ASSESSED AS INCONCLUSIVE. SEROMA-LATE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. NO OTHER OBSERVATIONS OBSERVED, NO FURTHER ACTIONS ARE REQUIRED.
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF SEROMA IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.
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.
VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: ¿ RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. ¿ SEROMA LATE: UNABLE TO OBSERVE AS IT IS NOT RELATED TO THE DEVICE. NO ADDITIONAL OBSERVATIONS. NO FURTHER ACTIONS ARE REQUIRED AS NO MANUFACTURING ISSUES ARE OBSERVED. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A.2., H.6.
PATIENT REPORTED A LEFT SIDE RUPTURE. COMPANY REPRESENTATIVE LATER REPORTED "RUPTURE AND SEROMA." DEVICE HAS BEEN EXPLANTED.
PATIENT REPORTED A LEFT SIDE RUPTURE. COMPANY REPRESENTATIVE LATER REPORTED "RUPTURE AND SEROMA." DEVICE HAS BEEN EXPLANTED.
PATIENT REPORTED A RUPTURE TO AN UNKNOWN SIDE. THIS RECORD REPRESENTS THE LEFT SIDE. DEVICE REMAINS IMPLANTED.
PATIENT REPORTED A LEFT SIDE RUPTURE. COMPANY REPRESENTATIVE LATER REPORTED "RUPTURE AND SEROMA." DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1465996 | STYLE 110 SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2231691 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Female | Required Intervention |