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: 2
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 350-2450
• Device Lot Number: 6404302
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 66