INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2022-01030
- Event Type
- Injury
- Date Received
- February 10, 2022
- Date of Event
- January 12, 2021
- Report Date
- July 3, 2023
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 10888628007147
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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. 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 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.
CORRECTED DATA: IN SUP MW 1 (MW 2780934), AWARE DATE SHOULD HAVE BEEN 21FEB2023 THE DATE EXPLANT WAS CONFIRMED.
DEVICE EVALUATION: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: CAPSULAR CONTRACTURE: UNABLE TO OBSERVE, AS IT IS A MEDICAL EVENT. NOT RELATED TO THE DEVICE. ADDITIONAL OBSERVATIONS: OBSERVED, CREASES ON THE DEVICE. WHITE PARTICLES OBSERVED, IN THE SURFACE OF THE SHELL. NO FURTHER ACTIONS ARE REQUIRED, AS THE DEVICE WAS IMPLANTED. REASON FOR REOPERATION: CAPSULAR CONTRACTURE, BAKER GRADE III.
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE IV. THE DEVICE REMAINS IMPLANTED.
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.
HEALTHCARE PROFESSIONAL CONFIRMED, CAPSULAR CONTRACTURE, BAKER GRADE III. THE DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59888 | INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | SRM-445 | 2864829 | 10888628007147 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female | Required Intervention |