BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIENTRA SILICONE GEL BREAST IMPLANTS

    MDR report key: 24316316 · Received February 11, 2026

    Report

    Report Number
    1651189-2026-10199
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    February 11, 2026
    Report Date
    February 11, 2026
    Manufacturer
    TIGER AESTHETICS MEDICAL
    Product Code
    FTR
    PMA / PMN Number
    P070004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 NO DISCOLORATION. THE DEVICE WEIGHED 303.1 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.

    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). 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.

    Description of Event or Problem · 0

    BILATERAL CAPSULAR CONTRACTURE, BAKER GRADE 3, LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13004 SIENTRA SILICONE GEL BREAST IMPLANTS SILICONE GEL BREAST IMPLANT FTR TIGER AESTHETICS MEDICAL 10621-XXXHP

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention