MAUDE Adverse Event Report: MENTOR SILICONE BREAST IMPLANTS

Model Number 350-3504BC

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

Patient Problems Fatigue (1849); Memory Loss/Impairment (1958); Pain (1994); Red Eye(s) (2038); Respiratory Distress (2045); Visual Impairment (2138); Joint Disorder (2373); Weight Changes (2607)

Event Date 12/16/2015

Event Type  Injury  

Event Description

Over time since implants.I have experienced fatigue, joint pain (hips), muscle soreness, red and sore eyes, weight gain, inability to take deep breaths, inability to lose weight , double vision and trouble recalling words.

• Brand Name: SILICONE BREAST IMPLANTS
• Type of Device: SILICONE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6279621
• MDR Text Key: 65941014
• Report Number: MW5067490
• 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: 01/25/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 350-3504BC
• Device Lot Number: 6713145
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: B12; FIBER; IODINE; IRON; NATURETHROID; PROBIOTICS ; SELENIUM; TUMERIC
• Patient Outcome(s): Disability
• Patient Age: 48 YR
• Patient Weight: 62