MAUDE Adverse Event Report: MENTOR MENTOR SMOOTH ROUND HIGH PROFILE SALINE IMPLANTS

Model Number	REF 350-3330
Medical Device Problem Codes	Deflation Problem (1149); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Capsular Contracture (1761); Pain (1994); Weight Changes (2607)
Date of Event	10/13/2010
Type of Reportable Event	Serious Injury
Event or Problem Description
My gallbladder had to be removed, due to it working only at 11% after nuclear testing.Severe pain in breasts started in 2016 along with drastic weight loss.An explant surgery on (b)(6) 2017, left was leaking and partially deflated.Right had capsular contracture.

• Brand Name: MENTOR SMOOTH ROUND HIGH PROFILE SALINE IMPLANTS
• Common Device Name: MENTOR SMOOTH ROUND HIGH PROFILE SALINE IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6961135
• Report Number: MW5072836
• Device Sequence Number: 14905283
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 10/17/2017
• 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
• Device Model Number: REF 350-3330
• Device Lot Number: 5840510
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Disability
• Patient Weight: 48