MAUDE Adverse Event Report: MENTOR BREAST IMPLANT

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Gastritis (1874); Unspecified Infection (1930); Menstrual Irregularities (1959); Pain (1994); Palpitations (2467)
Date of Event	10/20/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
Ongoing recurrent infections.Abnormal blood test results since 2012.Gi issues, pain.Menstrual period only twice or so a year (started in 2008 after implants).Palpitations.

• Brand Name: BREAST IMPLANT
• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6543640
• Report Number: MW5069555
• Device Sequence Number: 82544
• Product Code: FWM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 05/02/2017
• 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALEVE; AMBIEN; ATIVAN; IMITREX; TRAMADOL; VITAMIN D
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 48 YR
• Patient Weight: 58