MAUDE Adverse Event Report: MENTOR SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANTS

Model Number	350-1460
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	06/27/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
I developed reoccurring breast cellulitis due to 10 year old saline breast implants.

• Brand Name: SMOOTH ROUND SPECTRUM SALINE BREAST IMPLANTS
• Common Device Name: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6260478
• Report Number: MW5067289
• Device Sequence Number: 722846
• Product Code: FWM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 01/15/2017
• 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
• Device Model Number: 350-1460
• Device Lot Number: 5730849
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Weight: 86