BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 3913234 · Received June 11, 2014

    Report

    Report Number
    2024601-2014-00330
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    December 15, 2011
    Report Date
    March 5, 2013
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SUBMITTED ON (B)(6) 2014. DEVICE LABELING REVIEWED. TWO STUDIES IN HUMANS HAVE FOUND THAT THE RISK OF BIRTH DEFECTS OVERALL IS NOT INCREASED IN CHILDREN BORN AFTER BREAST IMPLANT SURGERY,

    Description of Event or Problem · 1

    PT REPORTED AN EVENT OF "OTHER, NEUROLOGICAL DIAGNOSIS, EPILEPSY." (VARIED INJURIES TO OFFSPRING OF PT) SIDE WAS UNSPECIFIED, THIS RECORD IS FOR THE RIGHT SIDE. SEE MFR 2024601-2014-00329 FOR THE LEFT SIDE .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343695 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT FTR ALLERGAN NA 1790378

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Congenital Anomaly