MAUDE Adverse Event Report: MENTOR SILICONE GEL IMPLANTS

Device Problem Insufficient Information (3190)

Patient Problems Autoimmune Disorder (1732); Connective Tissue Disease (1786); Lupus (1956)

Event Date 09/23/2013

Event Type  Injury  

Event Description

Mentor textured silicone gel implants.Caused autoimmune diseases ana connective tissue diseases.Currently, diagnosed systemic lupus.

• Brand Name: SILICONE GEL IMPLANTS
• Type of Device: SILICONE GEL IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6857674
• MDR Text Key: 85943980
• Report Number: MW5072104
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• 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: 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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Weight: 47