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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SILICONE HIGH PROFILE MEMORY GEL IMPLANTS

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MENTOR SILICONE HIGH PROFILE MEMORY GEL IMPLANTS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Headache (1880); High Blood Pressure/ Hypertension (1908); Memory Loss/Impairment (1958); Neuropathy (1983); Immunodeficiency (2156); Sleep Dysfunction (2517); Confusion/ Disorientation (2553)
Event Date 05/01/2016
Event Type  Injury  
Event Description
I had breast implants on (b)(6) 2016. I began suffering with a poor immune system, memory loss, brain fog, fatigue, insomnia, neuropathy, high blood pressure, migraines, eye sight and hearing and had to have tubes put into my ears and could not get out of bed most days. Implants robbed me of a year of my life!.
 
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Brand NameSILICONE HIGH PROFILE MEMORY GEL IMPLANTS
Type of DeviceSILICONE HIGH PROFILE MEMORY GEL IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6456467
MDR Text Key71768398
Report NumberMW5068880
Device Sequence Number1
Product Code FTR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/31/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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: 03/31/2017 Patient Sequence Number: 1
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