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U.S. Department of Health and Human Services

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

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MENTOR SMOOTH ROUND MODERATE PROFILE SALINE IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE Back to Search Results
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.
 
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Brand NameSMOOTH ROUND MODERATE PROFILE SALINE IMPLANT
Type of DevicePROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
Manufacturer (Section D)
MENTOR
MDR Report Key8311495
MDR Text Key135991679
Report NumberMW5083759
Device Sequence Number1
Product Code KWM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received02/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number350
Device Catalogue Number1670
Device Lot Number5632856
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
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