MAUDE Adverse Event Report: MENTOR SILICONE MEMORY GEL BREAST IMPLANTS

Model Number SILICONE MEMORY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Fatigue (1849); Gastritis (1874); Headache (1880); Blurred Vision (2137)

Event Date 11/30/2015

Event Type  Injury  

Event Description

Migraines, blurred vision, dizziness, chest pain, gallbladder stopped working without stones, chronic fatigue gastritis, chronic epstein barre, hashimoto thyroid, lyme disease and more.After breast cancer reconstruction.

• Brand Name: SILICONE MEMORY GEL BREAST IMPLANTS
• Type of Device: SILICONE MEMORY GEL BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6584736
• MDR Text Key: 75857794
• Report Number: MW5069932
• Device Sequence Number: 1
• Product Code: FTR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/21/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SILICONE MEMORY
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 71