MAUDE Adverse Event Report: MENTOR MENTOR SALINE BREAST IMPLANTS

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fatigue (1849); Pain (1994); Complaint, Ill-Defined (2331); Neck Pain (2433)
Date of Event	03/17/2004
Type of Reportable Event	Serious Injury
Event or Problem Description
I have been feeling terrible for at least the last ten years or more.I've seen drs, had tests, multiple lyme and blood tests, xrays, been to physical therapy but nothing.I have chronic symptoms such as bone pain, neck and back pain, brain fog, severe fatigue that affects my concentration and driving, stomach and digestive issues, and eye problems, etc.Among many symptoms that make me feel like i'm dying a slow death.I have come to learn that these symptoms are all from the mentor saline implants done back in (b)(6) 2004, which i cannot afford to have removed.Functioning in life is difficult and painful.My quality of life is very poor.

• Brand Name: MENTOR SALINE BREAST IMPLANTS
• Common Device Name: MENTOR SALINE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 7209059
• Report Number: MW5074696
• Device Sequence Number: 954396
• Product Code: FWM
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/17/2018
• 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Weight: 59