MAUDE Adverse Event Report: MENTOR MENTOR SMOOTH SPECTRUM SALINE IMPLANTS

Lot Number 222358

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/01/2017

Event Type  Injury  

Event Description

I have actually been sick since 2004, but your calendar only goes back to 2007. I have breast implant illness and will be having the implants explanted very soon. I'm trying to pick a doctor now.

• Brand Name: MENTOR SMOOTH SPECTRUM SALINE IMPLANTS
• Type of Device: MENTOR SMOOTH SPECTRUM SALINE IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6614215
• MDR Text Key: 76839167
• Report Number: MW5070182
• Device Sequence Number: 1
• Product Code: FWM
• 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: 06/02/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/17/2014
• Device Lot Number: 222358
• 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: 06/02/2017 Patient Sequence Number: 1