INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-01901
- Event Type
- Injury
- Date Received
- February 4, 2025
- Date of Event
- November 14, 2024
- Report Date
- April 10, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- 003
Narratives
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A2 B5 D6B D9 H3 H6. LABORATORY ANALYSIS SUMMARY- THE DEVICE RELATED TO THE REPORTED EVENTS CAPSULAR CONTRACTURE WAS RECEIVED ON MARCH 18, 2025 WITH LOT NUMBER 1210016. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINT CODES ARE: -CAPSULAR CONTRACTURE: UNABLE TO OBSERVE. AS PER THE INVESTIGATION PROCEDURE, CREASES AND WEAR ABRASION WERE OBSERVED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED.
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. REASON FOR REOPERATION: CAPSULAR CONTRACTURE BAKER GRADE IV. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.
THE DEVICE HAS BEEN EXPLANTED.
HEALTHCARE PROFESSIONAL REPORTED "CAPSULAR CONTRACTURES BAKER GRADE IV" THIS IS FOR THE RIGHT-SIDE DEVICE. THE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65167 | INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 1210016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Female | Required Intervention |