MAUDE Adverse Event Report: MENTOR BREAST IMPLANT

Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Swelling (2091); Complaint, Ill-Defined (2331); No Code Available (3191)
Date of Event	08/01/2006
Type of Reportable Event	Serious Injury
Event or Problem Description
Mastitis, swelling, nodules and varius other illness.Test (unk) dates but will get.Multiple symptoms continue.(b)(6) of this year started a severe decline in my health.Have various test.Pathology and currently waiting to explant.Trying to get original doctor surgeon to release my medical records.

• Brand Name: BREAST IMPLANT
• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 7027294
• Report Number: MW5073269
• Device Sequence Number: 10045155
• Product Code: FTR
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 11/09/2017
• 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?: Yes
• Operator of Device: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Disability
• Patient Weight: 60