MAUDE Adverse Event Report: MENTOR MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Pain (1994); Malaise (2359)
Date of Event	01/01/2007
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4).I actually started feeling ill within a year of my implants.I have been diagnosed with fibromyalgia, uterine cancer, ovarian cancer, chronic fatigue, food allergies, joint pain etc.None of which i had before implants.

• Brand Name: MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 7215051
• Report Number: MW5074780
• Device Sequence Number: 9737334
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 10/10/2017

1 Device was Involved in the Event

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 47.000 YR