SIENTRA SILICONE GEL BREAST IMPLANTS
Report
- Report Number
- 1651189-2025-09730
- Event Type
- Injury
- Date Received
- November 3, 2025
- Date of Event
- October 27, 2025
- Report Date
- October 30, 2025
- Manufacturer
- TIGER AESTHETICS MEDICAL
- Product Code
- FTR
- PMA / PMN Number
- P070004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
- Health Professional
- Yes
Narratives
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 CREASES AND LIGHT YELLOWING. THE DEVICE WEIGHED 474.0 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. 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.
LEFT-SIDE MAMMOGRAPHY INDICATED RUPTURE AND BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE 4, LEFT SIDE. CAPSULAR CONTRACTURE DATE OF EVENT: 04/02/2026.
LEFT-SIDE MAMMOGRAPHY INDICATED RUPTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1558803 | SIENTRA SILICONE GEL BREAST IMPLANTS | SILICONE GEL BREAST IMPLANT | FTR | TIGER AESTHETICS MEDICAL | 10712-XXXMP | A43581 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | Required Intervention |