BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIGH PROFILE SILICONE BREAST IMPLANT

    MDR report key: 3050273 · Received April 4, 2013

    Report

    Report Number
    MW5029682
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    November 10, 2010
    Report Date
    April 4, 2013
    Manufacturer
    MENTOR WORLDWIDE LLC
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RUPTURE OF MENTOR SILICONE GEL BREAST IMPLANT. BECAME VERY ILL. DIAGNOSED WITH FIBROMYALGIA, CHRONIC FATIGUE SYNDROME, POTS AND MULTIPLE CHEMICAL SENSITIVITIES. UNABLE TO FUNCTION OR WORK. DOSE: BILATERAL, FREQUENCY: 2005, ROUTE: IM. DATES OF USE: (B)(6) 2005 - (B)(6) 2011. REASON FOR USE: BREAST CANCER RECONSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137616 HIGH PROFILE SILICONE BREAST IMPLANT SILICONE BREAST IMPLANT 300 CC FTR MENTOR WORLDWIDE LLC
    137818 HIGH PROFILE SILICONE BREAST IMPLANT SILICONE BREAST IMPLANT 350 CC FTR MENTOR WORLDWIDE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| S