SIENTRA SILICONE GEL BREAST IMPLANTS
Report
- Report Number
- 1651189-2025-09678
- Event Type
- Injury
- Date Received
- October 17, 2025
- Date of Event
- September 17, 2025
- Report Date
- October 16, 2025
- Manufacturer
- TIGER AESTHETICS MEDICAL
- Product Code
- FTR
- PMA / PMN Number
- P070004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- 003
Narratives
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. CORRECTION: B5.
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 LIGHT YELLOWING. THE DEVICE WEIGHED 417.4 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). 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.
RIGHT-SIDE LATE FORMING SEROMA AND BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE 1-2, RIGHT SIDE. CAPSULAR CONTRACTURE DATE OF EVENT: 10/09/2025.
RIGHT-SIDE LATE FORMING SEROMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322521 | SIENTRA SILICONE GEL BREAST IMPLANTS | SILICONE GEL BREAST IMPLANT | FTR | TIGER AESTHETICS MEDICAL | 10621-XXXHP | A45747 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Female | Required Intervention |