MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANTS

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Muscle Weakness (1967); Respiratory Distress (2045); Visual Impairment (2138); Tingling (2171); Anxiety (2328); Arthralgia (2355); Numbness (2415); Ambulation Difficulties (2544); Cognitive Changes (2551); Confusion/ Disorientation (2553)
Date of Event	08/01/2007
Type of Reportable Event	Serious Injury
Event or Problem Description
I was actually sick from 2008 - 2015 from mentor saline breast implants.My symptoms started two weeks after getting them.Extreme anxiety, numbness tingling, severe joint pain, brain fog, memory loss, confusion, vision problems, major food allergies, difficulty walking, malabsorption, breathing issues, muscle atrophy, hormonal issues.I had a full hysterectomy six months after getting the implants.

• Brand Name: SALINE BREAST IMPLANTS
• Common Device Name: SALINE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6857635
• Report Number: MW5072099
• Device Sequence Number: 14736441
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2015
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 09/09/2017
• 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?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 41 YR
• Patient Weight: 56