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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SILICONE GEL IMPLANTS

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MENTOR SILICONE GEL IMPLANTS Back to Search Results
Event Date 09/23/2013
Event Type  Injury  
Event Description

Mentor textured silicone gel implants. Caused autoimmune diseases ana connective tissue diseases. Currently, diagnosed systemic lupus.

 
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Brand NameSILICONE GEL IMPLANTS
Type of DeviceSILICONE GEL IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6857674
Report NumberMW5072104
Device Sequence Number2
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 09/09/2017
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received09/12/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
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

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