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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR IMPLANTS

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MENTOR MENTOR IMPLANTS Back to Search Results
Event Date 07/13/2015
Event Type  Injury  
Event Description

I had implants put in 10 years ago. I immediately became ill with migraines, rheumatoid arthritis, pots, sjogrens, lupus and celiac disease. I was disabled for many years. I explanted on (b)(6) 2015 and found the valves to my mentor implants were faulty and created a situation where mold was present. I am doing 95% better and don't have any signs of 4 out of 5 autoimmune issues. They ruined 10 years of my life and because of my age, i missed having children because i was so sick.

 
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Brand NameMENTOR IMPLANTS
Type of DeviceMENTOR IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key5332814
Report NumberMW5058779
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 12/23/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/23/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/23/2015 Patient Sequence Number: 1
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