BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH SALINE

    MDR report key: 8842133 · Received July 30, 2019

    Report

    Report Number
    MW5088470
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    June 1, 2006
    Report Date
    July 26, 2019
    Manufacturer
    MENTOR
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MENTOR SALINE SMOOTH BREAST IMPLANTS. HAIR LOSS, PREMATURE AGING, JOINT AND MUSCLE PAIN, BRAIN FOG, TEETH AND TONGUE PROBLEMS; SEVERE DEPRESSION, RASHES, LYMPH NODES TENDER AND SWOLLEN, OPEN SORES; TROUBLE BREATHING, ANXIETY, HIGH BLOOD PRESSURE, ACNE, MEMORY LOSS, DRY SKIN, EAR INFECTIONS; WEAK IMMUNE SYSTEM, SEVERE STOMACH PAIN, WEIGHT LOSS (5 FEET 6 INCHES, (B)(6)); TEMPERATURE SENSITIVITY, SWEATING AND BODY ODOR, DIFFICULTY SWALLOWING, PERSISTENT COUGH, CHRONIC FATIGUE, FIBROMYALGIA SYMPTOMS; BACK PAIN, NECK AND SHOULDER PAIN (WENT FROM AN A CUP TO A B), SUICIDAL THOUGHTS. I CAN NO LONGER COUNT OR DO SIMPLE MATH. I FEEL THAT MY WHOLE BODY AND LIFE HAVE BEEN STOLEN FROM MY FAMILY AND MYSELF. I HAVE SEEN DRS THAT TELL ME I AM HEALTHY. LAB WORK COMES BACK NORMAL. HOW CAN I BE HEALTHY AND FEEL THIS BAD PHYSICALLY? IT TOOK A LOT FOR ME TO GO TO A DR AS I LIVE A HOLISTIC LIFESTYLE, JUST TO BE TOLD IT'S ALL IN MY HEAD. WHAT ELSE COULD THEY HAVE TOLD ME? THEY WANTED TO HELP BUT WITHOUT ALL THE INFO, THEY WERE NOT ABLE. REGARDLESS, I SHOULD HAVE BEEN HEARD. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636519 MENTOR SMOOTH SALINE PROSTHESIS, BREAST, INFLATABLE INTERNAL SALINE FWM MENTOR 5600000
    636520 MENTOR SMOOTH SALINE PROSTHESIS, BREAST, INFLATABLE INTERNAL SALINE FWM MENTOR

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Congenital Anomaly| L| S