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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/17/2014
• Device Lot Number: 222358
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 49 YR
• Patient Weight: 86