BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH SALINE IMPLANTS

    MDR report key: 9213991 · Received October 18, 2019

    Report

    Report Number
    MW5090497
    Event Type
    Injury
    Date Received
    October 18, 2019
    Date of Event
    April 1, 2015
    Report Date
    October 17, 2019
    Manufacturer
    MENTOR
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SALINE MENTOR IMPLANTS (YEAR IMPLANTED - 2013) CHRONIC FATIGUE, AUTO-IMMUNE TYPE SYMPTOMS, BRAIN FOG, SLEEP APNEA, JOINT AND MUSCLE PAIN, PAIN IN BOTH BREASTS, SUDDEN FOOD INTOLERANCE, MIGRAINES, TEMPERATURE INTOLERANCE, VERTIGO, ETC. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005303 MENTOR SMOOTH SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE INTERNAL SALINE FWM MENTOR
    1005304 MENTOR SMOOTH SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE INTERNAL SALINE FWM MENTOR

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| L| S