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Super Search Devices@FDA
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MENTOR BREAST IMPLANT Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Autoimmune Reaction (1733); Fatigue (1849); Muscle Weakness (1967); Rash (2033); Sweating (2444); Confusion/ Disorientation (2553)
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 Name
Type of Device
Manufacturer (Section D)
MDR Report Key6773548
MDR Text Key82171974
Report NumberMW5071436
Device Sequence Number1
Product Code FTR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
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
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age50 YR
Patient Weight56