BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND SALINE

    MDR report key: 12438663 · Received September 7, 2021

    Report

    Report Number
    MW5103752
    Event Type
    Injury
    Date Received
    September 7, 2021
    Date of Event
    May 1, 2017
    Report Date
    September 2, 2021
    Manufacturer
    MENTOR WORLDWIDE LLC
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FOR A WHILE I HAVE BEEN BRUSHED OUT. LARGE LIVER. HAIR LOSS BRAIN FOG. PAIN IN BACK NECK AND SHOULDER. UNEXPLAINABLE WEIGHT GAIN. TREATMENT AFTER TREATMENT. MEDS AFTER MEDS. DEPRESSION. EVERYONE THOUGHT I WAS CRAZY. MY IMPLANTS ARE POISONING ME. AND THE FACT IS WE CAN'T FIND HELP IS VERY SAD. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328522 MENTOR SMOOTH ROUND SALINE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR WORLDWIDE LLC
    1328523 MENTOR SMOOTH ROUND SALINE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR WORLDWIDE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other