BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE GEL BREAST IMPLANT

    MDR report key: 8252850 · Received January 15, 2019

    Report

    Report Number
    MW5083119
    Event Type
    Injury
    Date Received
    January 15, 2019
    Date of Event
    January 1, 2014
    Report Date
    January 10, 2019
    Manufacturer
    MENTOR TEXAS LP
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DIAGNOSED WITH HASHIMOTO'S THYROID DISEASE AFTER GETTING SILICONE GEL BREAST IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44016 SILICONE GEL BREAST IMPLANT PROSTHESIS, BREAST NON-INFLATABLE, INTERNAL SILICONE GEL FILLED FTR MENTOR TEXAS LP
    44017 SILICONE GEL BREAST IMPLANT PROSTHESIS, BREAST NON-INFLATABLE, INTERNAL SILICONE GEL FILLED FTR MENTOR TEXAS LP

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Disability