MAUDE Adverse Event Report: MENTOR SILICONE BREAST IMPLANTS

Model Number	350-3504BC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Memory Loss/Impairment (1958); Pain (1994); Red Eye(s) (2038); Respiratory Distress (2045); Visual Impairment (2138); Joint Disorder (2373); Weight Changes (2607)
Date of Event	12/16/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Over time since implants.I have experienced fatigue, joint pain (hips), muscle soreness, red and sore eyes, weight gain, inability to take deep breaths, inability to lose weight , double vision and trouble recalling words.

• Brand Name: SILICONE BREAST IMPLANTS
• Common Device Name: SILICONE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6279621
• Report Number: MW5067490
• Device Sequence Number: 9484962
• Product Code: FTR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 01/25/2017
• 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?: No
• Operator of Device: No Information
• Device Model Number: 350-3504BC
• Device Lot Number: 6713145
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: B12; FIBER; IODINE; IRON; NATURETHROID; PROBIOTICS ; SELENIUM; TUMERIC
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 48 YR
• Patient Weight: 62