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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
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
Report NumberMW5072634
Device Sequence Number1
Product CodeFTR
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 LAY USER/PATIENT
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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