SIENTRA SILICONE GEL BREAST IMPLANTS
Report
- Report Number
- 1651189-2026-10412
- Event Type
- Injury
- Date Received
- April 1, 2026
- Date of Event
- March 24, 2026
- Report Date
- March 25, 2026
- 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). ADDITIONAL INFORMATION: D6B, H6, B5. 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: 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 WHITE/CLOUDY. THE DEVICE WEIGHED 237.6 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 CAPSULAR CONTRACTURE, BAKER GRADE 4 AND RIGHT-SIDE LATE FORMING SEROMA. DATE OF EVENT FOR SEROMA: 4/22/2026.
RIGHT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE 3.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 545802 | SIENTRA SILICONE GEL BREAST IMPLANTS | SILICONE GEL BREAST IMPLANT | FTR | TIGER AESTHETICS MEDICAL | 10621-XXXMP | A47994 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |