MAUDE Adverse Event Report: MENTOR BREAST IMPLANT SILICONE

Catalog Number	350-5501BC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Fatigue (1849); Hair Loss (1877); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Tingling (2171); Anxiety (2328); Depression (2361); Numbness (2415); Confusion/ Disorientation (2553); No Code Available (3191)
Date of Event	07/29/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
Received mentor silicone breast implants on (b)(6) 2013.Have had several health issues since.Extreme fatigue, migraines, digestive issues, worsening depression/anxiety, brain fog, memory issues, hair loss, numbness and tingling in left arm and leg, breast pain, chest pain.Explanting asap.

• Brand Name: BREAST IMPLANT SILICONE
• Common Device Name: BREAST IMPLANT SILICONE
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6857663
• Report Number: MW5072103
• Device Sequence Number: 17098475
• Product Code: FTR
• Combination Product (Y/N): N
• 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): 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
• Device Catalogue Number: 350-5501BC
• Device Lot Number: 6514842
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 39 YR
• Patient Weight: 63