BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORY GEL BREAST INPLANTS

    MDR report key: 10786391 · Received November 3, 2020

    Report

    Report Number
    MW5097649
    Event Type
    Injury
    Date Received
    November 3, 2020
    Date of Event
    May 24, 2017
    Report Date
    November 3, 2020
    Manufacturer
    MENTOR WORLDWIDE, LLC
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IMMEDIATELY AFTER SURGERY REPORTER STATES THAT SHE GOT A RASH AND HIVES. THREE MONTHS LATER WEIGHT GAIN, JOINT PAIN, DIETARY REACTIONS, BLOATING, SWELLING, GAS, FATIGUE, BRAIN FOG, AND HAS A PRELIMINARY DIAGNOSIS FOR ENVIRONMENTAL EXPOSURE GENE MUTATION JAK 2 WHICH CAN LEAD TO BLOOD CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247685 MENTOR MEMORY GEL BREAST INPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR WORLDWIDE, LLC
    1247686 MENTOR MEMORY GEL BREAST INPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR WORLDWIDE, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other