BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIENTRA OPUS SILICONE GEL BREAST IMPLANT

    MDR report key: 8622100 · Received May 17, 2019

    Report

    Report Number
    1651189-2019-00173
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    April 3, 2019
    Report Date
    May 17, 2019
    Manufacturer
    SIENTRA, INC.
    Product Code
    FTR
    PMA / PMN Number
    P070004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DIAGNOSED WITH CAPSULAR CONTRACTURE, BAKER GRADE IV, LEFT-SIDE DEVICE, WITHIN 3 MOS. OF IMPLANTATION DATE. DEVICE REMOVED AND REPLACED WITH IDENTICAL DEVICE.

    Description of Event or Problem · 1

    PATIENT DIAGNOSED WITH CAPSULAR CONTRACTURE, BAKER GRADE IV - LEFT-SIDE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415455 SIENTRA OPUS SILICONE GEL BREAST IMPLANT SILICONE GEL BREAST IMPLANT FTR SIENTRA, INC. 10621-XXXMP

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention