MAUDE Adverse Event Report: MENTOR SILICONE HIGH PROFILE MEMORY GEL IMPLANTS

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Headache (1880); High Blood Pressure/ Hypertension (1908); Memory Loss/Impairment (1958); Neuropathy (1983); Immunodeficiency (2156); Sleep Dysfunction (2517); Confusion/ Disorientation (2553)
Date of Event	05/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
I had breast implants on (b)(6) 2016.I began suffering with a poor immune system, memory loss, brain fog, fatigue, insomnia, neuropathy, high blood pressure, migraines, eye sight and hearing and had to have tubes put into my ears and could not get out of bed most days.Implants robbed me of a year of my life!.

• Brand Name: SILICONE HIGH PROFILE MEMORY GEL IMPLANTS
• Common Device Name: SILICONE HIGH PROFILE MEMORY GEL IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6456467
• Report Number: MW5068880
• Device Sequence Number: 743559
• Product Code: FTR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 03/31/2017
• 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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Other; Disability
• Patient Age: 23 YR
• Patient Weight: 57