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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SILICONE BREAST IMPLANTS

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MENTOR SILICONE BREAST IMPLANTS Back to Search Results
Model Number 350-3504BC
Event Date 12/16/2015
Event Type  Injury  
Event Description

Over time since implants. I have experienced fatigue, joint pain (hips), muscle soreness, red and sore eyes, weight gain, inability to take deep breaths, inability to lose weight , double vision and trouble recalling words.

 
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Brand NameSILICONE BREAST IMPLANTS
Type of DeviceSILICONE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6279621
Report NumberMW5067490
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 01/25/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received01/25/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number350-3504BC
Device LOT Number6713145
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: 01/25/2017 Patient Sequence Number: 1
Treatment
B12
FIBER
IODINE
IRON
NATURETHROID
PROBIOTICS
SELENIUM
TUMERIC
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