BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SALINE BREAST IMPLANTS

    MDR report key: 8310912 · Received February 5, 2019

    Report

    Report Number
    MW5083742
    Event Type
    Injury
    Date Received
    February 5, 2019
    Date of Event
    January 1, 1998
    Report Date
    February 3, 2019
    Manufacturer
    MENTOR
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IMPLANTS CAUSING MULTIPLE PROBLEMS IN MY BODY. AUTOIMMUNE, SENSORY, CHRONIC FATIGUE SYNDROME, FIBROMYALGIA, IRRITABLE BOWEL SYNDROME, ETC¿LINKED TO BREAST IMPLANTS ILLNESS. ROUTE: GIVEN INTO/UNDER THE SKIN. DATES OF USE: 22 YEARS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO. IS THE PRODUCT COMPOUNDED? NO. IS THE PRODUCT OVER-THE-COUNTER? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102089 MENTOR SALINE BREAST IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL SALINE FWM MENTOR

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability