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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SILTEX GEL-FILLED MAMMARY SALINE BREAST IMPLANTS

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MENTOR SILTEX GEL-FILLED MAMMARY SALINE BREAST IMPLANTS Back to Search Results
Model Number 354-1308G
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Asthma (1726); Chronic Obstructive Pulmonary Disease (COPD) (2237); Cancer (3262)
Event Date 01/01/2000
Event Type  Injury  
Event Description
I have been on a decline in my health since i had implants placed over the muscle in 2000. I have had thyroid cancer, parathyroid tumors, thyroidectomy with parathyroidectomies, inability to work for over one year, fibromyalgia, asthma and copd the list goes on and on. I also have become intolerant to smells and chemicals.
 
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Brand NameSILTEX GEL-FILLED MAMMARY
Type of DeviceSALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6964346
MDR Text Key89952945
Report NumberMW5072846
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 Number354-1308G
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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