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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SILICONE IMPLANTS BREAST IMPLANTS
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MENTOR SILICONE IMPLANTS BREAST IMPLANTS Back to Search Results
Model Number 354-2007
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Fatigue (1849); Headache (1880); Inflammation (1932); Pain (1994); Skin Discoloration (2074); Blurred Vision (2137); Weakness (2145); Burning Sensation (2146); Anxiety (2328); Depression (2361); Weight Changes (2607)
Event Date 01/09/2000
Event Type  Injury  
Event Description
In 1998, i had a reconstructive surgery and mentor brand, textured, silicone implants were implanted. My first symptoms in early 2000 with migraines. Then depression and daily anxiety became an issue. I have been on prescription medications for those. Around 2005, i started having raynaud's disease which always affects my nipple and toes when cold. Here are all the ongoing symptoms: migraines, anxiety, fatigue, temperature intolerance, sensitivity to smells, burning pain in breasts, inflammation in breasts, weakness, chronic back pain, whole body dryness, pigment discoloration, blurred vision, word retrieval, concentration, and rapid weight gain.
 
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Brand NameSILICONE IMPLANTS
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6964414
MDR Text Key89934499
Report NumberMW5072854
Device Sequence Number1
Product Code FTR
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 10/18/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number354-2007
Device Lot Number177709
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: 10/20/2017 Patient Sequence Number: 1
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