MAUDE Adverse Event Report: MENTOR SMOOTH ROUND MODERATE PLUS PROFILE GEM IMPLANT; BREAST IMPLANT

Model Number	350-3251BC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Unspecified Infection (1930); Immunodeficiency (2156); Joint Disorder (2373); Neck Pain (2433)
Date of Event	08/12/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
Began with pain in joints/muscles of the neck, led to other infections and weakened immune system, followed by growing pain in joints and extreme fatigue.

• Brand Name: SMOOTH ROUND MODERATE PLUS PROFILE GEM IMPLANT
• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6459767
• Report Number: MW5068891
• Device Sequence Number: 16423455
• Product Code: FTR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 04/04/2017
• 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
• Device Model Number: 350-3251BC
• Device Lot Number: 5947419
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OTC MEDS: MULTIVITAMIN; PROBIOTIC; RX MEDS: NA
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 45 YR
• Patient Weight: 59