MAUDE Adverse Event Report: MENTOR SMOOTH ROUND MOD PLUS PROFILE - SALINE; BREAST IMPLANTS

Model Number	350-2450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Pain (1994); Thyroid Problems (2102); Arthralgia (2355); Palpitations (2467)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Adrenal fatigue, hypothyroidism, hashimotos, back and shoulder pain on left side, lower back pain - left side, heart palpitations.

• Brand Name: SMOOTH ROUND MOD PLUS PROFILE - SALINE
• Common Device Name: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6669671
• Report Number: MW5070658
• Device Sequence Number: 9733350
• Product Code: FWM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 06/24/2017
• 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: 350-2450
• Device Lot Number: 6460261
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Weight: 66