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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SILICONE BREAST IMPLANT

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MENTOR SILICONE BREAST IMPLANT Back to Search Results
Event Date 01/07/2007
Event Type  Injury  
Event Description

I had mentor silicone breast implants in (b)(6) 2007. For the past several years i have had many health issues from fatigue to swollen lymph nodes that will not go away, and a lot of things in between. I have been to several doctors and specialists over the year with no help or definite answers. An e. N. T. Dr i went to questioned me about my implants and suggested, i think about having them removed. I am researching that option now.

 
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Brand NameSILICONE BREAST IMPLANT
Type of DeviceSILICONE BREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6875928
Report NumberMW5072203
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 09/17/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received09/18/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
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: 09/18/2017 Patient Sequence Number: 1
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