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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR BREAST IMPLANT

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MENTOR BREAST IMPLANT Back to Search Results
Event Date 05/05/2001
Event Type  Injury  
Event Description

I got mentor implants. Started feeling ill within a year, by year 3 i was so sick my labs pointed to lupus or sjogrens. Have had so many tests/labs and everything from chronic fatigue, fibromyalgia, sjogrens, non-specific autoimmune, rashes, brain fog, body aches, night sweats, headaches, muscle weakness, always cold. Can't handle the sun anymore, can no longer jog/run. Some days can't get out of bed.

 
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Brand NameBREAST IMPLANT
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6773548
Report NumberMW5071436
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 08/06/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received08/06/2017
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: 08/06/2017 Patient Sequence Number: 1
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