BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE BREAST IMPLANTS

    MDR report key: 9706195 · Received February 12, 2020

    Report

    Report Number
    MW5092957
    Event Type
    Injury
    Date Received
    February 12, 2020
    Date of Event
    April 30, 2003
    Report Date
    February 9, 2020
    Manufacturer
    MENTOR WORLDWIDE, LLC
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PLACEMENT OF BILATERAL BREAST IMPLANTS ON (B)(6) 2003, [375 CC SMOOTH, ROUND, MODERATE PROFILE, SALINE IMPLANT PLACED IN (RIGHT BREAST): MENTOR REFERENCE #350-1655, SN # (B)(4)]; [375 CC SMOOTH, ROUND, MODERATE PROFILE, SALINE IMPLANT PLACED IN (LEFT BREAST): MENTOR REFERENCE #350-1655, SN # (B)(4)]. SYMPTOMS HAVE OCCURRED GRADUALLY SINCE THEN AND NOW ARE EXTREMELY DAMAGING AND CONSISTING OF: ACHY PAIN UNDER MY LEFT COLLARBONE (RESEMBLING BUILD UP OF CO2), BURNING SENSATION ACROSS ABDOMEN, ACHY/CRACKING BONES, BURNING, TIGHTENING, CHOKING-LIKE PRESSURE (LEFT SIDE) DEEP UNDER BREAST RADIATING TO MY BACK, INSOMNIA, CHRONIC VAGINAL YEAST FLUID UNDER EYES, SWOLLEN AND INFLAMED EYES, BLOODSHOT EYES, BRITTLE-LIKE FEELING EYEBALLS, BROKEN CAPILLARIES IN EYES, CLEAR BLISTERING IN LEFT EYE, BLURRY, HAZY VISION IN BOTH EYES, VERY STRONG SWEET-SMELLING URINE, NON-STOP, RINGING IN EARS, THYROID ISSUES, INTERMITTENT CONSTIPATION, BURNING SENSATION IN BLADDER RESEMBLING A UTI (HOWEVER UTI TESTS X TWO NEGATIVES), PAINFUL BONE SPUR ON RIGHT SIDE OF RIGHT FOOT, MILDLY ITCHY BUMPS RESEMBLING MOSQUITO BITS ON SCALP, HAIR LOSS, COARSE HAIR (STRAW-LIKE) FEELING; ABSORBS SHAMPOO AND CONDITIONER DIFFERENTLY ACHY PAIN NOW UNDER MY RIGHT COLLARBONE (RESEMBLING BUILD UP OF CO2) AS WELL, INCREASING WAVES OF NAUSEA, BUT NOT CONSISTENT. PUNCHED IN THE STOMACH FEELING, DAILY HANGOVER FEELING. SERIOUS HEALTH OCCURRENCES OF UNKNOWN ETIOLOGY INCLUDE: ¿MEGA LIVER MEASURING 24¿ OBSERVED ON MRI IN BOTH 2017 AND 2019. ELEVATED CPK BLOOD LAB LEVELS .INFARCTED SPLEEN (SPLENECTOMY (B)(6) 2017). NOTE: BOTH BREAST IMPLANTS ARE STILL INSIDE OF ME AWAITING MY SCHEDULED EXPLANT ON (B)(6) 1010. FDA SAFELY REPORT ID # (B)(4). FDA RECEIVED DATE: 02/06/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166906 SALINE BREAST IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL ,SALINE FWM MENTOR WORLDWIDE, LLC #350-1655
    166907 SALINE BREAST IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL , SALINE FWM MENTOR WORLDWIDE, LLC #350-1655

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R| S