MAUDE Adverse Event Report: MENTOR MENTOR BREAST IMPLANT

Model Number	350-2325
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Autoimmune Disorder (1732); Fatigue (1849); Hair Loss (1877); Thyroid Problems (2102); Cognitive Changes (2551); Weight Changes (2607)
Date of Event	01/04/2008
Type of Reportable Event	Serious Injury
Event or Problem Description
Mentor saline breast implants caused hashimotos and sjogrens auto immune.Hair loss, fatigue, brain fog, weight gain.

• Brand Name: MENTOR BREAST IMPLANT
• Common Device Name: MENTOR BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6224791
• Report Number: MW5067035
• Device Sequence Number: 809917
• Product Code: FWM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2016
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 01/02/2017
• 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: 350-2325
• Device Lot Number: 5689013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MILK THISTLE; MULTI VITAMIN; VITAMIN D; VITAMIN K2
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 36 YR
• Patient Weight: 82