MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS (SALINE)

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Autoimmune Disorder (1732)
Date of Event	05/15/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
Mentor saline breast implants that i got in 2003.I have several autoimmune diseases and symptoms related to the implants.I believe i have bii (breast implant illness).

• Brand Name: BREAST IMPLANTS (SALINE)
• Common Device Name: BREAST IMPLANTS (SALINE)
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6656713
• Report Number: MW5070530
• Device Sequence Number: 17556966
• Product Code: FWM
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/19/2017
• 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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 43 YR
• Patient Weight: 63