STYLE 68 SALINE FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2022-12211
- Event Type
- Injury
- Date Received
- July 22, 2022
- Report Date
- October 25, 2022
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FWM
- PMA / PMN Number
- P990074
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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.
DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF DEFLATION AND OTHER-TECHNICAL WAS RECEIVED ON SEPTEMBER 16, 2022 WITH LOT NUMBER 1181401. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: DEFLATION: OBSERVED, ONE OPENING IN ANTERIOR SIDE ASSESSED AS FOLD FLAW OPENING. OTHER-TECHNICAL: OBSERVED BROWN PARTICLES IN THE FILL CHANNEL. ADDITIONAL OBSERVATIONS: WEAR ABRASION IS OBSERVED. CREASE IS OBSERVED. NO FURTHER ACTIONS ARE REQUIRED AS THE DEVICE WAS IMPLANTED.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, D6B, H6.
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.
HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
HEALTHCARE PROFESSIONAL LATER REPORTED LEFT SIDE "PARTICLES IN VALVE". DEVICE HAS BEEN EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 109124 | STYLE 68 SALINE FILLED BREAST IMPLANT | PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE | FWM | ALLERGAN (COSTA RICA) | 1181401 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |