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

Model Number REF 350-3330

Device Problems Deflation Problem (1149); Fluid/Blood Leak (1250)

Patient Problems Capsular Contracture (1761); Pain (1994); Weight Changes (2607)

Event Date 10/13/2010

Event Type  Injury  

Event 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
• Type of Device: MENTOR SMOOTH ROUND HIGH PROFILE SALINE IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6961135
• MDR Text Key: 89847786
• Report Number: MW5072836
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: REF 350-3330
• Device Lot Number: 5840510
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Weight: 48