BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST IMPLANTS

    MDR report key: 6935627 · Received October 10, 2017

    Report

    Report Number
    MW5072656
    Event Type
    Injury
    Date Received
    October 10, 2017
    Report Date
    October 5, 2017
    Manufacturer
    MCGHAN
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BREAST IMPLANT ILLNESS; DECLINING HEALTH, ONSET OF RA, MCD, BLEEDING DISORDER, EXTREME FATIGUE AND BREAST PAIN, CONSTANT AND WORSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718884 BREAST IMPLANTS BREAST IMPLANTS FTR MCGHAN LG0281
    718885 BREAST IMPLANTS BREAST IMPLANTS FTR MCGHAN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability