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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
Device Problem Insufficient Information (3190)
Patient Problems Autoimmune Disorder (1732); Connective Tissue Disease (1786); Lupus (1956)
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 Name
SILICONE GEL IMPLANTS
Type of Device
SILICONE GEL IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6857674
MDR Text Key85943980
Report NumberMW5072104
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 09/09/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/12/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Disability;
Patient Weight47
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