BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIENTRA SILICONE GEL BREAST IMPLANTS

    MDR report key: 23681710 · Received December 1, 2025

    Report

    Report Number
    1651189-2025-09865
    Event Type
    Injury
    Date Received
    December 1, 2025
    Date of Event
    August 20, 2025
    Report Date
    December 1, 2025
    Manufacturer
    TIGER AESTHETICS MEDICAL
    Product Code
    FTR
    PMA / PMN Number
    P070004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    TIGER AESTHETICS MEDICAL COMPLAINT#: (B)(4). TIGER AESTHETICS MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    TIGER AESTHETICS MEDICAL COMPLAINT #: (B)(4). 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.

    Description of Event or Problem · 0

    LEFT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE 4.

    Description of Event or Problem · 0

    LEFT-SIDE CAPSULAR CONTRACTURE, BAKER GRADE 4 AND LEFT-SIDE LATE FORMING SEROMA. DATE OF EVENT FOR LATE FORMING SEROMA: 1/19/2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2443308 SIENTRA SILICONE GEL BREAST IMPLANTS SILICONE GEL BREAST IMPLANT FTR TIGER AESTHETICS MEDICAL 20721-XXXMP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention