STYLE 68 SALINE FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2021-59300
- Event Type
- Injury
- Date Received
- January 5, 2022
- Date of Event
- December 1, 2021
- Report Date
- October 26, 2022
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FWM
- PMA / PMN Number
- P990074
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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. 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: DEFLATION.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D.9, H.3 ,H.6 DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF DEFLATION WAS RECEIVED ON JUNE 08, 2022 WITH LOT NUMBER 1231297. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: ¿ DEFLATION OBSERVED AN OPENING ASSESSED AS ADHESIVE FAILURE. ADDITIONAL OBSERVATIONS: ¿ CREASE FOLD OBSERVED IN THE DEVICE. ¿ YELLOW PARTICLES INSIDE OBSERVED IN THE DEVICE. NO FURTHER ACTIONS ARE REQUIRED AS THE DEVICE WAS IMPLANTED.
PATIENT REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
DEVICE HAS BEEN EXPLANTED.
PATIENT REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 739937 | STYLE 68 SALINE FILLED BREAST IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN (COSTA RICA) | 1231297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Female | Required Intervention| R |