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U.S. Department of Health and Human Services

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

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MENTOR MENTOR SILICONE HIGH PROFILE BREAST IMPLANTS Back to Search Results
Model Number SMOOTH FOUND ULTRA HIGH PROFILE
Event Type  Injury  
Event 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.

 
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Brand NameMENTOR SILICONE HIGH PROFILE
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6578006
Report NumberMW5069874
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 05/17/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received05/17/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberSMOOTH FOUND ULTRA HIGH PROFILE
Device Catalogue Number350-5480BC
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 05/17/2017 Patient Sequence Number: 1
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