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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR CORP. MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SILICONE GEL

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MENTOR CORP. MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SILICONE GEL Back to Search Results
Catalog Number 350-3751BC
Event Date 02/13/2014
Event Type  Injury  
Event Description

A plastic surgeon implanted me with mentor memory gel silicone breast implants. I started becoming ill after a few months. I have many chronic illnesses that i never had before including: pain in my breasts, joints, bones, arthritis, migraine headaches and dizziness, aversion to smells and taste, dry skin, canker sores in mouth, throat and swallowing problems, chronic fatigue, memory problems, gerd, insomnia, ear ringing, restless leg syndrome, forgetfulness, anxiety and panic attacks, swelling, inflammation all over body, weight gain in upper extremities.

 
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Brand NameMENTOR SMOOTH ROUND MODERATE PLUS PROFILE SILICONE GEL
Type of DeviceMENTOR SMOOTH ROUND MODERATE PLUS PROFILE SILICONE GEL
Manufacturer (Section D)
MENTOR CORP.
MDR Report Key6237879
Report NumberMW5067157
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 01/06/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received01/06/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue Number350-3751BC
Device LOT Number6783952
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? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/06/2017 Patient Sequence Number: 1
Treatment
CYMBALTA
MINERAL REPLACEMENT SUPPLEMENTS
MOTRIN 800 MG
OTC MEDS: ALEVE
RX MEDS: MOBIC
ZANTAC
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