SIENTRA SILICONE GEL BREAST IMPLANTS
Report
- Report Number
- 1651189-2025-09363
- Event Type
- Injury
- Date Received
- August 23, 2025
- Date of Event
- July 18, 2022
- Report Date
- August 22, 2025
- Manufacturer
- TIGER AESTHETICS MEDICAL
- Product Code
- FTR
- PMA / PMN Number
- P070004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
TIGER AESTHETICS MEDICAL COMPLAINT #: (B)(4). AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. TIGER AESTHETICS MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
TIGER AESTHETICS MEDICAL COMPLAINT #: (B)(4). DEVICE EVALUATION: D6B, D9, G3, G6, H2, H3, H6, H10. TIGER AESTHETICS MEDICAL RECEIVED THE SUSPECTED DEVICE FROM THE CUSTOMER AND PERFORMED A FAILURE ANALYSIS. THE DEVICE WAS RETURNED INTACT AND FUNCTIONAL WITH MODERATE YELLOWING. THE DEVICE WEIGHED 375.7 GRAMS. NO ADDITIONAL OBSERVATIONS. TIGER AESTHETICS MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
TIGER AESTHETICS MEDICAL COMPLAINT#: (B)(4). ADDITIONAL INFORMATION: H6. TIGER AESTHETICS MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
LEFT-SIDE MALPOSITION.
LEFT-SIDE MALPOSITION AND BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE 4, LEFT-SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2280937 | SIENTRA SILICONE GEL BREAST IMPLANTS | SILICONE GEL BREAST IMPLANT | FTR | TIGER AESTHETICS MEDICAL | RBASE-XXXHP | 714918 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Female | Required Intervention |