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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SILICONE MEMORY GEL BREAST IMPLANTS

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MENTOR SILICONE MEMORY GEL BREAST IMPLANTS Back to Search Results
Model Number SILICONE MEMORY
Event Date 11/30/2015
Event Type  Injury  
Event Description

Migraines, blurred vision, dizziness, chest pain, gallbladder stopped working without stones, chronic fatigue gastritis, chronic epstein barre, hashimoto thyroid, lyme disease and more. After breast cancer reconstruction.

 
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Brand NameSILICONE MEMORY GEL BREAST IMPLANTS
Type of DeviceSILICONE MEMORY GEL BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6584736
Report NumberMW5069932
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 05/21/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received05/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberSILICONE MEMORY
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: 05/21/2017 Patient Sequence Number: 1
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