MAUDE Adverse Event Report: MENTOR MENTOR HP IMPLANTS BREAST IMPLANTS

Model Number 350CC

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

Patient Problems Memory Loss/Impairment (1958); Nausea (1970); Seizures (2063); Blurred Vision (2137); Tingling (2171); Dizziness (2194); Depression (2361); Cognitive Changes (2551); Confusion/ Disorientation (2553); Alteration In Body Temperature (2682)

Event Date 11/20/2016

Event Type  Injury  

Event Description

Brain fog, dizzy, memory loss, nausea, seizures, blurred vision. Tingling in hands and feet, temperatures problems, depression, confusion.

• Brand Name: MENTOR HP IMPLANTS
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 7009576
• MDR Text Key: 91441719
• Report Number: MW5073169
• 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: Unknown
• Type of Report: Initial
• Report Date: 11/04/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 350CC
• Device Catalogue Number: 350-3504
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 11/08/2017 Patient Sequence Number: 1