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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS (SALINE)
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MENTOR BREAST IMPLANTS (SALINE) Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Autoimmune Disorder (1732)
Event Date 05/15/2013
Event Type  Injury  
Event Description
Mentor saline breast implants that i got in 2003. I have several autoimmune diseases and symptoms related to the implants. I believe i have bii (breast implant illness).
 
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Brand NameBREAST IMPLANTS (SALINE)
Type of DeviceBREAST IMPLANTS (SALINE)
Manufacturer (Section D)
MENTOR
MDR Report Key6656713
MDR Text Key78174549
Report NumberMW5070530
Device Sequence Number1
Product Code FWM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/19/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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: 06/19/2017 Patient Sequence Number: 1
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