BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIENTRA SILICONE GEL-FILLED BREAST IMPLANT

    MDR report key: 3954657 · Received July 18, 2014

    Report

    Report Number
    1651189-2014-00023
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    March 1, 2014
    Report Date
    July 17, 2014
    Manufacturer
    SIENTRA, INC
    Product Code
    FTR
    PMA / PMN Number
    P070004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SILICONE GEL BREAST IMPLANT - PATIENT DIAGNOSED WITH BAKER GRADE IV CAPSULAR CONTRACTURE - RIGHT SIDE. DEVICE REMOVED AND REPLACED WITH IDENTICAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423088 SIENTRA SILICONE GEL-FILLED BREAST IMPLANT FTR SIENTRA, INC 20621

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other