BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR

    MDR report key: 12301345 · Received August 9, 2021

    Report

    Report Number
    MW5103109
    Event Type
    Injury
    Date Received
    August 9, 2021
    Date of Event
    February 28, 2009
    Report Date
    August 5, 2021
    Manufacturer
    JOHNSON & JOHNSON / MENTOR WORLDWIDE, LLC.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FIRST TIME-BREAST AUGMENTATION, INSERTED WITH TEXTURED SILICON BREAST IMPLANTS ON (B)(6) 2007, USING MENTOR - MEMORY GEL, BY J & J., 8 MONTHS LATER, I BEGAN FEELING FATIGUE, BRAIN FOG, JOINT PAIN AND FINALLY DIAGNOSED (B)(6) 2009 RHEUMATOID ARTHRITIS. ON (B)(6) 2008 I WAS ACCEPTED TO PARTICIPATE IN MEMORYGEL BREAST IMPLANT POST APPROVAL 10 YEAR STUDY. ON (B)(6) 2014, I WAS REMOVED FROM THE STUDY BY MENTOR. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191374 MENTOR PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR JOHNSON & JOHNSON / MENTOR WORLDWIDE, LLC. UNK UNK
    1191375 MENTOR PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR JOHNSON & JOHNSON / MENTOR WORLDWIDE, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention| S