MAUDE Adverse Event Report: MENTOR SMOOTH MODERATE PROFILE BREAST IMPLANT

Model Number 350-1660

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Pain (1994); Weight Changes (2607)

Event Date 01/01/2015

Event Type  Injury  

Event Description

Sudden decline in health and increase in pain of area of implants as well as systemically.Chronic fatigue, weight gain, inability to be active.

• Brand Name: SMOOTH MODERATE PROFILE BREAST IMPLANT
• Type of Device: SMOOTH MODERATE PROFILE BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6581398
• MDR Text Key: 75761177
• Report Number: MW5069908
• Device Sequence Number: 1
• Product Code: FWM
• 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: 05/18/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 350-1660
• Device Lot Number: 5593914
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 33 YR
• Patient Weight: 70