MAUDE Adverse Event Report: MENTOR TEXTURED SILICONE IMPLANT

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling (2091)
Date of Event	07/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
I have mentor breast implants for reconstruction from cancer 2015.In a matter of 48 hours - one breast swelled and i went to see my plastic surgeon.

• Brand Name: TEXTURED SILICONE IMPLANT
• Common Device Name: TEXTURED SILICONE IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6773348
• Report Number: MW5071419
• Device Sequence Number: 14811571
• Product Code: FTR
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 08/04/2017
• 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?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 55 YR
• Patient Weight: 61