SIENTRA SILICONE GEL BREAST IMPLANTS
Report
- Report Number
- 1651189-2025-09494
- Event Type
- Injury
- Date Received
- September 15, 2025
- Date of Event
- July 21, 2025
- Report Date
- September 11, 2025
- Manufacturer
- TIGER AESTHETICS MEDICAL
- Product Code
- FTR
- PMA / PMN Number
- P070004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
TIGER AESTHETICS MEDICAL COMPLAINT #: (B)(4). ADDITIONAL INFORMATION: G3, G6, H2, H3, H6, H10. TIGER AESTHETICS MEDICAL WAS UNABLE TO PERFORM AN EVALUATION AS THE DEVICE WAS DISCARDED BY THE CUSTOMER. 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 LIGHT YELLOWING. (B)(4). NO ADDITIONAL OBSERVATIONS. 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). 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.
CORRECTION: B5.
BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE 3, RIGHT SIDE.
RIGHT-SIDE CAPSULAR CONTRACTURE BAKER GRADE 2-3.
RIGHT-SIDE CAPSULAR CONTRACTURE BAKER GRADE 3.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 526512 | SIENTRA SILICONE GEL BREAST IMPLANTS | SILICONE GEL BREAST IMPLANT | FTR | TIGER AESTHETICS MEDICAL | 10621-XXXHP | A45911 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |