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

Model Number 350-3251BC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Unspecified Infection (1930); Immunodeficiency (2156); Joint Disorder (2373); Neck Pain (2433)

Event Date 08/12/2013

Event Type  Injury  

Event 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
• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6459767
• MDR Text Key: 71907636
• Report Number: MW5068891
• Device Sequence Number: 2
• Product Code: FTR
• 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: 04/04/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 350-3251BC
• Device Lot Number: 5949856
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: MULTIVITAMIN; PROBIOTIC; RX MEDS: NA
• Patient Outcome(s): Disability
• Patient Age: 45 YR
• Patient Weight: 59