BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIENTRA SILICONE GEL BREAST IMPLANTS

    MDR report key: 24505272 · Received March 4, 2026

    Report

    Report Number
    1651189-2026-10310
    Event Type
    Injury
    Date Received
    March 4, 2026
    Date of Event
    February 19, 2026
    Report Date
    March 3, 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

    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. H3 OTHER TEXT: DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    RIGHT-SIDE MAMMOGRAPHY INDICATED RUPTURE.

    Description of Event or Problem · 0

    RIGHT-SIDE MAMMOGRAPHY INDICATED RUPTURE AND RIGHT-SIDE DOUBLE BUBBLE. DATE OF EVENT FOR DOUBLE BUBBLE: 3/16/2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186736 SIENTRA SILICONE GEL BREAST IMPLANTS SILICONE GEL BREAST IMPLANT FTR TIGER AESTHETICS MEDICAL 10512-XXXMP

    Patients

    Seq Age Sex Outcome Treatment
    1