BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIENTRA SILICONE GEL-FILLED BREAST IMPLANT

    MDR report key: 3962625 · Received July 15, 2014

    Report

    Report Number
    1651189-2014-00021
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    March 19, 2014
    Report Date
    July 15, 2014
    Manufacturer
    SIENTRA, INC
    Product Code
    FTR
    PMA / PMN Number
    P070004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SILICONE GEL BREAST IMPLANT - PATIENT REPORTED RIGHT SIDE DEVICE APPEARED HIGHER AND FELT DIFFERENT THAN LEFT SIDE DEVICE. PHYSICAL EXAMINATION BY PHYSICIAN INDICATED BAKER III CAPSULAR CONTRACTURE. DEVICE REMOVED AND REPLACED WITH IDENTICAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412266 SIENTRA SILICONE GEL-FILLED BREAST IMPLANT FTR SIENTRA, INC 20621

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other