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

Model Number 350-2450

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

Patient Problems Fatigue (1849); Pain (1994); Thyroid Problems (2102); Arthralgia (2355); Palpitations (2467)

Event Date 01/01/2016

Event Type  Injury  

Event 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
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6669671
• MDR Text Key: 78650485
• Report Number: MW5070658
• 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: 06/24/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 350-2450
• Device Lot Number: 6460261
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 06/24/2017 Patient Sequence Number: 1