MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANT

Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Fatigue (1849); Arthralgia (2355); Cognitive Changes (2551)
Date of Event	04/01/2009
Type of Reportable Event	Serious Injury
Event or Problem Description
Insidious health problems increasing in severity over a four year period after breast implant procedure to include; debilitating fatigue, chronic and debilitating joint pain, and cognitive dysfunction.

• Brand Name: SALINE BREAST IMPLANT
• Common Device Name: SALINE BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6566553
• Report Number: MW5069759
• Device Sequence Number: 12280549
• Product Code: FWM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2017
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 05/11/2017
• 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?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COLOSTRUM; MAGNESIUM; MONOLAURIN; OTC MEDS: VITAMIN D; PROBIOTICS; RX MEDS: FLORINEF; TRAMADOL; VITAMIN C
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 40 YR
• Patient Weight: 64