MAUDE Adverse Event Report: MENTOR SMOOTH ROUND MODERATE PROFILE SALINE IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number 350

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

Patient Problems Dry Eye(s) (1814); Fatigue (1849); Hair Loss (1877); Memory Loss/Impairment (1958); Confusion/ Disorientation (2553); Weight Changes (2607)

Event Date 01/01/2015

Event Type  Injury  

Event Description

I¿ve had implants for 13 years. Roughly 4 years ago i started feeling a decline in my health following my third pregnancy. I attributed it all to being (b)(6) years old and hormones out of whack. My hair was falling out in clumps. It hasn¿t grown back in. I¿m extremely tired every day. I have dry eyes, dark circles, and red capillaries all the time. My memory is horrendous. It¿s called brain fog. I can¿t even remember movie plots anymore. I¿ve also put on weight which i¿ve blamed on pregnancies and age. There¿s just no energy for exercise. It¿s a battle. My immune system seems weaker than my family members. I get sick more frequently and hold onto them longer. Sinus infections and colds. My thyroid was tested by my doctor and found to be normal. Because my tests were normal, i truly believed i was getting old, tired, and forgetful. This has been going on for 4 years.

• Brand Name: SMOOTH ROUND MODERATE PROFILE SALINE IMPLANT
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR
• MDR Report Key: 8311495
• MDR Text Key: 135991679
• Report Number: MW5083759
• Device Sequence Number: 1
• Product Code: KWM
• Combination Product (y/n): N
• 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: 02/03/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 350
• Device Catalogue Number: 1670
• Device Lot Number: 5632856
• Was Device Available for Evaluation?: Yes
• 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: 02/05/2019 Patient Sequence Number: 1