BEUDAMED
    FDA Adverse Event Summary report: N

    STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 3946320 · Received July 10, 2014

    Report

    Report Number
    2024601-2014-00340
    Date Received
    July 10, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALLERGAN SILICON DEVICE LABELING: EFFECTS ON CHILDREN: "CONCERNS HAVE BEEN RAISED REGARDING POTENTIAL DAMAGING EFFECTS ON CHILDREN BORN TO MOTHERS WITH IMPLANTS. TWO STUDIES IN HUMANS HAVE FOUND THAT THE RISK OF BIRTH DEFECTS OVERALL IS NOT INCREASED IN CHILDREN BORN AFTER BREAST IMPLANT SURGERY. THERE WERE NO CASES REPORTED OF RAYNAUD'S PHENOMENON IN PATIENTS IN THE ALLEGAN CORE STUDY.

    Description of Event or Problem · 1

    PATIENT REPORTED "(B)(6) YEAR OLD DAUGHTER WAS BORN WITH A MILD FORM OF DWARFISM CALLED SPONDYLOEPIPHYSEAL DYSPLASIA CONGENITA", A RARE DISORDER OF BONE GROWTH THAT RESULTS IN DWARFISM. FOR THE PATIENT, THE EVENT OF RAYNAUD'S SYNDROME IS REPORTED. DEVICE REMAINS IMPLANTED. THIS FILE IS FOR THE LEFT SIDE. SEE MFR #2024601-2014-00341 FOR THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402544 STYLE 115 SILICONE GEL FILLED BREAST IMPLANT FTR FTR ALLERGAN NA 1381701

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention