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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SMOOTH ROUND AND MODERATE PROFILE SALINE SALINE BREAST IMPLANTS

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MENTOR MENTOR SMOOTH ROUND AND MODERATE PROFILE SALINE SALINE BREAST IMPLANTS Back to Search Results
Model Number 350-1655
Event Date 06/10/2005
Event Type  Injury  
Event Description

I became very ill, diagnosed with fibromyalgia, capsular contra (grade 3 and 4) many symptoms to include; chronic body pain, breast pain, chronic fatigue, hair loss, muscle, joint weakness and pain, ringing in ears, ibs, insomnia, anxiety, depression, tingling and pins and needles in hands and feet, headaches, weight gain, food intolerances, shoulder, neck, back, arms, hands, leg and foot pain, heart palpitations, shortness of breath, inflammation, diagnosed with fibromyalgia and arthritis, breast tumors and cysts. Shortness of breath, night sweats and hot flashes, nausea, lightheadedness, brain fog, poor concentration. Unable to work.

 
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Brand NameMENTOR SMOOTH ROUND AND MODERATE PROFILE SALINE
Type of DeviceSALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6529987
Report NumberMW5069435
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 04/26/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received04/26/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number350-1655
Device LOT Number5595588
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: 04/26/2017 Patient Sequence Number: 1
Treatment
CYCLOBENZAPRINE
EPSILON SALT BATHS.
ESTRADIOL
IBUPROFEN.
INDOMETHACIN
MULTIVITAMIN
OMEGA 3
OTC MEDS: VITAMIN D
OXYCODONE
PROBIOTICS
PROPRANOLOL
PROZAC
RX MEDS: LOSARTIN
TRAZADONE
TUMERIC
TYLENOL
VITAMIN B12
VITAMIN C
WOMEN'S DAILY
XANAX
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