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

Model Number	350-1655
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	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)
Date of Event	06/10/2005
Type of Reportable Event	Serious Injury
Event or Problem 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.

• Brand Name: MENTOR SMOOTH ROUND AND MODERATE PROFILE SALINE
• Common Device Name: SALINE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6529987
• Report Number: MW5069435
• Device Sequence Number: 11705827
• Product Code: FWM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: 350-1655
• Device Lot Number: 5595588
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 50 YR
• Patient Weight: 79