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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SMOOTH MPP BREAST IMPLANTS

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MENTOR MENTOR SMOOTH MPP BREAST IMPLANTS Back to Search Results
Model Number 350-350 1BC
Event Date 12/31/2009
Event Type  Injury  
Event Description

I had to have a double mastectomy in 2009 with immediate breast implants. I have been extremely sick about 1 year after surgery. I am getting sicker and sicker. I have called the surgeon that performed the surgery to get in for check up. I have state insurance as of 2012 after being too ill to work full time and my dr does not accept this insurance. I have not been followed up with after my last post-up appointment in 2010. I have 3 children and i'm extremely scared that i'm going to die from this illness. Please help me before i lose my life.

 
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Brand NameMENTOR SMOOTH MPP BREAST IMPLANTS
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6990022
Report NumberMW5073053
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 10/27/2017
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received10/31/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number350-350 1BC
Device LOT Number5791187
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

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