STYLE 115 SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2024-15651
- Event Type
- Injury
- Date Received
- June 24, 2024
- Report Date
- July 26, 2024
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS RUPTURE AND CAPSULAR CONTRACTURE WAS RECEIVED ON JULY 22, 2024. WITH LOT NUMBER 2142364. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE ¿ CAPSULAR CONTRACTURE: UNABLE TO OBSERVE. ¿ RUPTURE: OBSERVED AN OPENING ASSESSED AS SURGICAL DAMAGE AS PER THE INVESTIGATION PROCEDURE, PARTICLES, CREASES AND WEAR ABRASION WERE 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 8/19/2024.
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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 REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION: RUPTURE, CAPSULAR CONTRACTURE BAKER GRADE III.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: H6. VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. 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.
PHYSICIAN REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED
PHYSICIAN REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
PHYSICIAN REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
PHYSICIAN REPORTED LEFT SIDE CAPSULAR CONTRACTURE BAKER GRADE III AND RUPTURE. DEVICE HAS BEEN EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 448550 | STYLE 115 SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2142364 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |