STYLE 15 SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2022-17382
- Event Type
- Injury
- Date Received
- October 12, 2022
- Report Date
- December 15, 2022
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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: DEVICE DEFLATION.
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9, H3, H6. DEVICE EVALUATION: BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: RUPTURE: ONE OPENING ON RADIUS SIDE ASSESSED AS A SURGICAL IMPACT OPENING. ADDITIONAL OBSERVATIONS: CREASES WERE OBSERVED. STRESS MARKS OBSERVED.
REASON FOR REOPERATION:RUPTUREDEVICE EVALUATION:BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE:¿ RUPTURE: ONE OPENING ON RADIUS SIDE ASSESSED AS A SURGICAL IMPACT OPENING.ADDITIONAL OBSERVATIONS: ¿ CREASES WERE OBSERVED.¿ STRESS MARKS OBSERVED.
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE IS EXPLANTED.
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE IS EXPLANTED.
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE RUPTURE. DEVICE IS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2565905 | STYLE 15 SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 1726029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |