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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MEMORY GEL BREAST IMPLANT

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MENTOR MEMORY GEL BREAST IMPLANT Back to Search Results
Model Number 350-4001BC
Event Date 07/01/2015
Event Type  Injury  
Event Description

I had a breast augmentation on (b)(6) 2015. Since that day i've suffered the following abnormal weight gain, chronic fatigue, brain fog, diagnosed thrush, lack of energy, dry eyes, lack of concentration, dizziness, inflammation, dry skin and hair, estrogen imbalance. Sudden food intolerance to gluten, shortness of breath, liver dysfunction and cramping. As time continues to pass, more symptoms seem to be showing up.

 
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Brand NameMEMORY GEL BREAST IMPLANT
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6533466
Report NumberMW5069445
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 04/27/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received04/27/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number350-4001BC
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: 04/27/2017 Patient Sequence Number: 1
Treatment
ADRENAL SUPPORT
FISH OIL
MACA ROOT
MULTI-VITAMIN
PROBIOTIC
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