BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMOOTH RND HIGH GEL MAMMARY PROSTH

    MDR report key: 8460015 · Received March 27, 2019

    Report

    Report Number
    MW5085268
    Event Type
    Injury
    Date Received
    March 27, 2019
    Date of Event
    March 1, 2007
    Report Date
    March 25, 2019
    Manufacturer
    MENTOR
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER HAVING MENTOR HIGH GEL (SILICONE) AUGMENTATION FIRST THING I NOTICED WAS MY LEFT BREAST DROPPED. WENT TO MY PS AND ASKED ABOUT IT AND WAS TOLD THAT I HAD AN INFECTION THAT WENT TO THAT BREAST AND TO ALWAYS REQUEST ANTIBIOTICS WITH DENTAL SERVICES. I WAS A VERY HEALTHY PERSON UNTIL MY IMPLANTS. HAD A BLADDER MESH SURGERY IN 2008, MANY ER VISITS, 3 COLONOSCOPY, 1 UPPER GI, UPPER AND LOWER JAW SURGERY DUE TO HEALTH ISSUE, SKIN CANCER, MOHS SURGERY, MANY LABS WITH HIGH AND LOW WBC, RBC, (B)(6), CHRONIC MONO, CHRONIC VBC, MIGRAINES, JOINT PAIN (HIPS, BACK, NECK, HANDS, KNEES, FINGERS) BRAIN FOG, MUSCLE WEAKNESS, STROKE, MEMORY LOSS, EXTREME WEIGHT LOSS, VISION CHANGES, GUT ISSUES, ANXIETY, FATIGUE, HAIR LOSS, THINNING NAILS, ARTHRITIS, INFLAMMATION, POOR SLEEP, DRY EYES, HYSTERECTOMY, LOW LIBIDO, I BRUISE EASILY, SLOW TO HEALING, CONSTANT THROAT CLEARING AND MUCUS, REFLEX, DIZZINESS, NIGHT SWEATS, SKIN RASHES, PAIN BEHIND EYES, SHORTNESS OF BREATH (STRUGGLE WITH BREATHING), NIPPLE PAIN, RECURRING INFECTIONS, SWOLLEN TENDER LYMPH NODES & GLANDS JAW LINE, NECK, THROAT, ARMPIT, GROIN & NEAR COLLAR BONE, MASSES REMOVED OFF LEFT BREAST, LEFT BREAST RUPTURE, SHARP PAIN IN BREAST AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247923 SMOOTH RND HIGH GEL MAMMARY PROSTH PROSTHESIS, BREAST, NON INFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR 350-3754BC 5641960

    Patients

    Seq Age Sex Outcome Treatment
    0 Hospitalization| R| S