MAUDE Adverse Event Report: MENTOR MENTOR SMOOTH SPECTRUM SALINE IMPLANTS

Lot Number	222358
Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	06/01/2017
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: MENTOR SMOOTH SPECTRUM SALINE IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6614215
• Report Number: MW5070182
• Device Sequence Number: 909708
• Product Code: FWM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 06/02/2017
• 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?: No
• Operator of Device: No Information
• Device Expiration Date: 05/17/2014
• Device Lot Number: 222358
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 49 YR
• Patient Weight: 86