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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SILICONE GEL IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED

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MENTOR SILICONE GEL IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED Back to Search Results
Model Number 35045048C
Device Problem Insufficient Information (3190)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 03/13/2013
Event Type  Injury  
Event Description
Had breast implants put in and have had failing health since. Just came across the breast implant illness.
 
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Brand NameSILICONE GEL IMPLANTS
Type of DevicePROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED
Manufacturer (Section D)
MENTOR
MDR Report Key6922108
MDR Text Key88862939
Report NumberMW5072634
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 10/04/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/04/2017
Device Model Number35045048C
Device Lot Number6558914
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: 10/06/2017 Patient Sequence Number: 1
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