MAUDE Adverse Event Report: MENTOR MENTOR SILICONE HIGH PROFILE; BREAST IMPLANTS

Model Number	SMOOTH FOUND ULTRA HIGH PROFILE
Health Effect - Clinical Codes	Autoimmune Disorder (1732); Bacterial Infection (1735); Cellulitis (1768); Dehydration (1807); Dyspnea (1816); Edema (1820); Erythema (1840); Fatigue (1849); Headache (1880); Hemorrhage/Blood Loss/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Itching Sensation (1943); Pneumonia (2011); Rash (2033); Increased Sensitivity (2065); Swelling (2091); Thyroid Problems (2102); Tissue Damage (2104); Toxic Shock Syndrome (2108); Visual Impairment (2138); Weakness (2145); Burning Sensation (2146); Tingling (2171); Myalgia (2238); Pressure Sore/Ulcer (2326); Arthralgia (2355); Numbness (2415); Respiratory Tract Infection (2420); Choking (2464); Sleep Dysfunction (2517); Ambulation or Postural Difficulties (2544); Weight Changes (2607); Alteration In Body Temperature (2682); Fibrosis (3167)
Type of Reportable Event	Serious Injury
Event or Problem Description
Began with recurring upper respiratory infections, cellulitis infections, staph infections, lymphedema put on 100 pounds.Fibromyalgia, ms symptoms high blood pressure, chronic fatigue, ibs burning sensation in body, frostbite sensations on outside of my body.Unexplained rashes, difficulty walking and breathing, pain in my joints, couldn't touch my body.Sensitivity to heat, sunlight and florescent lighting.Dryness of mouth, hair, skin, and scalp sores, choking at night afraid, i wouldn't wake up.Difficulty sleeping.Toxic shock symptoms, corrective tissue disease, vision issues, headaches, nose bleeds, recurring pneumonia.Extreme swelling throughout my body had to use a lymphatic drainage machine 2xs per day for 75 minutes.Team of doctors at (b)(6) clinic couldn't figure out what was happening to me.Complex case, a lot going on and they couldn't treat me successfully.Told me to go to (b)(46 clinic.I felt like i was dying.Could barely walk.Tingling and numbness in face, hands, and feet.Burning red rash on my eyelids.Redness all over my body.Auto immune disease, hands were swollen, red, and itchy.Feet red swollen to deformity.Can't wear socks or shoes only flip flops.I have had blood tests urine testing, ct scans, mris, and neurological testing.I had silicone implants put in (b)(6) 2014 and by (b)(6) 2015, i was getting sick.I was systemic.Very weak, couldn't walk a flight of stairs.I couldn't breathe, thought i have heart attack.Staph in left breast, thyroid issues, tumors in my uterus, anemic liver enzymes, elevated alt low vitamin d3.My body couldn't sweat couldn't get rid of toxins.Medtronic and adrenal issues.

• Brand Name: MENTOR SILICONE HIGH PROFILE
• Common Device Name: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6578006
• Report Number: MW5069874
• Device Sequence Number: 114266
• Product Code: FTR
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/17/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: SMOOTH FOUND ULTRA HIGH PROFILE
• Device Catalogue Number: 350-5480BC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Disability
• Patient Age: 52 YR
• Patient Weight: 122