MAUDE Adverse Event Report: MENTOR MENTOR SALINE BREAST IMPLANT

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Asthma (1726); Autoimmune Disorder (1732); Cyst(s) (1800); Fungus (1872); Hypersensitivity/Allergic reaction (1907); Hernia (2240); Cognitive Changes (2551); Weight Changes (2607); No Code Available (3191)
Date of Event	12/27/2010
Type of Reportable Event	Serious Injury
Event or Problem Description
I got mentor saline breast implants.Within 6 months i developed autoimmune disorder; candida cystic acne, unexplained weight gain, cold sores, toe nail fungus, brain fog.Within a year i developed a hernia, then had another hernia the following year.After 4 years i developed a cyst in my right shoulder that was so large it had to be surgically removed.I also developed asthma, and allergies to foods that were never an issue before.

• Brand Name: MENTOR SALINE BREAST IMPLANT
• Common Device Name: MENTOR SALINE BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6975780
• Report Number: MW5072931
• Device Sequence Number: 12181043
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 10/23/2017
• 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: 10/25/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Weight: 76