MAUDE Adverse Event Report: MENTOR MENTOR SMOOTH GEL BREAST IMPLANT

Model Number 350-3501BC

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

Patient Problems Fatigue (1849); Pain (1994); Swelling (2091); Weight Changes (2607); No Code Available (3191)

Event Date 11/30/2016

Event Type  Injury  

Event Description

Two weeks after getting great implants, lymph nodes began to swell and are still swollen.Right implant capsulated and became painful.C reactive protein is measuring 48 or higher.Six months after implants got (b)(6), along with unexplained weight loss, reoccurring shingles, and fatigue.The list goes on.

• Brand Name: MENTOR SMOOTH GEL BREAST IMPLANT
• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 7027562
• MDR Text Key: 91938750
• Report Number: MW5073308
• 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: 11/12/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 350-3501BC
• Device Catalogue Number: 350-3501BC
• 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 Weight: 47