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

Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Fatigue (1849); Pain (1994)
Date of Event	04/01/2008
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4).Chronic fatigue, body pain, brain fog, dry eyes.

• Brand Name: MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6533711
• Report Number: MW5069456
• Device Sequence Number: 1023001
• 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): 04/28/2017

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: 05/01/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43.000 YR