STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2024-05134
- Event Type
- Injury
- Date Received
- March 26, 2024
- Date of Event
- August 18, 2023
- Report Date
- May 2, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P040046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D.9, H.3, H.6. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE WAS RECEIVED ON JUNE 12, 2024, WITH LOT NUMBER 2093905. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: CAPSULAR CONTRACTURE: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. AS PER THE INVESTIGATION PROCEDURE DEFORMATION, CREASE WEAR ABRASION WAS COMPLETED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.
CORRECTION TO G.3. AWARE DATE OF SUPPLEMENTAL MEDWATCH #2. AWARE DATE SHOULD HAVE BEEN LISTED AS 02/JUL/2024.
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A2, A5, A6, B5, E3.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: H6, H10. VISUAL ANALYSIS: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: CAPSULAR CONTRACTURE: 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.
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THE EVENT OF CAPSULAR CONTRACTURE 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/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. PHOTOS OF THE EXPLANTED DEVICE HAVE BEEN RECEIVED; EVALUATION YET TO BEGIN. REASON FOR REOPERATION: CAPSULAR CONTRACTURE, BAKER GRADE IV.
PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV DIAGNOSED VIA ULTRASOUND AND PALPATION. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV DIAGNOSED VIA ULTRASOUND AND PALPATION. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE BAKER GRADE IV DIAGNOSED VIA ULTRASOUND AND PALPATION. THE DEVICE HAS BEEN EXPLANTED AND REPLACED WITH NON-ABBVIE DEVICE.
PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV DIAGNOSED VIA ULTRASOUND AND PALPATION. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
PATIENT REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV DIAGNOSED VIA ULTRASOUND AND PALPATION. THE DEVICE HAS BEEN EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3556 | STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2093905 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Female | Required Intervention |