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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyst(s) (1800); Dyspnea (1816); Fainting (1847); Fatigue (1849); Hair Loss (1877); Headache (1880); Inflammation (1932); Memory Loss/Impairment (1958); Muscle Weakness (1967); Nausea (1970); Pain (1994); Tinnitus (2103); Hot Flashes/Flushes (2153); Tingling (2171); Myalgia (2238); Anxiety (2328); Complaint, Ill-Defined (2331); Depression (2361); Neck Pain (2433); Sweating (2444); Palpitations (2467); Sleep Dysfunction (2517); Weight Changes (2607)
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 Name
MENTOR SMOOTH ROUND AND MODERATE PROFILE SALINE
Type of Device
SALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6529987
MDR Text Key74122014
Report NumberMW5069435
Device Sequence Number1
Product Code FWM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/26/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/26/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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
Patient Outcome(s) Disability;
Patient Age50 YR
Patient Weight79
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