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Super Search Devices@FDA
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MENTOR BREAST IMPLANT Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Inflammation (1932); Swelling (2091); Complaint, Ill-Defined (2331); No Code Available (3191)
Event Date 08/01/2006
Event Type  Injury  
Event Description
Mastitis, swelling, nodules and varius other illness.Test (unk) dates but will get.Multiple symptoms continue.(b)(6) of this year started a severe decline in my health.Have various test.Pathology and currently waiting to explant.Trying to get original doctor surgeon to release my medical records.
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Brand Name
Type of Device
Manufacturer (Section D)
MDR Report Key7027294
MDR Text Key92094483
Report NumberMW5073269
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 11/09/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
Patient Weight60