BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIENTRA SILICONE GEL BREAST IMPLANTS

    MDR report key: 22194999 · Received June 12, 2025

    Report

    Report Number
    1651189-2025-09007
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    May 29, 2025
    Report Date
    June 9, 2025
    Manufacturer
    SIENTRA SILICONE GEL BREAST IMPLANTS
    Product Code
    FTR
    PMA / PMN Number
    P070004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIENTRA COMPLAINT#: (B)(4). DEVICE EVALUATION: D9, G3, G6, H2, H3, H6, H10. SIENTRA RECEIVED THE SUSPECTED DEVICE FROM THE CUSTOMER AND PERFORMED A FAILURE ANALYSIS. THE DEVICE WAS RETURNED AND FOUND TO HAVE LIGHT YELLOWING. THE DEVICE WEIGHED 387.3 GRAMS. NO ADDITIONAL OBSERVATIONS. SIENTRA WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    SIENTRA COMPLAINT #: (B)(4). AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. SIENTRA 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 4, RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2013579 SIENTRA SILICONE GEL BREAST IMPLANTS SILICONE GEL BREAST IMPLANT FTR SIENTRA SILICONE GEL BREAST IMPLANTS 10621-XXXMP A25874

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Required Intervention