STYLE 68 SALINE FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2023-01543
- Event Type
- Injury
- Date Received
- February 13, 2023
- Report Date
- July 8, 2023
- 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 COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: DEFLATION: OBSERVED, BROKEN STRIATED ON ANTERIOR SIDE ASSESSED, AS SURGICAL DAMAGE. AND MISSING PIECE OF SHELL ASSESSED, AS INCONCLUSIVE. ADDITIONAL OBSERVATIONS: CREASE FOLD OBSERVED, WEAR ABRASION OBSERVED. NO FURTHER ACTIONS ARE REQUIRED, AS THE DEVICE WAS IMPLANTED.
VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: DEFLATION: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. OBSERVED PATCH LOT NUMBER 1101937. DEVICE ANALYSIS PERFORMED THROUGH PHOTOGRAPHS, DUE TO THE IMPOSSIBILITY TO PERFORM MICROSCOPIC ANALYSIS IT IS NOT POSSIBLE TO DETERMINE THE MOST LIKELY FAILURE MODE.
FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION IS: DEFLATION.
PATIENT CALLED TO REPORT, A LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED AND REPLACED.
DEVICE HAS BEEN EXPLANTED.
PATIENT CALLED TO REPORT A LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 682161 | STYLE 68 SALINE FILLED BREAST IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN (COSTA RICA) | 1101937 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |