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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR BREAST IMPLANT SILICONE GEL, SMOOTH RND MODERATE PLUS PROFILE BREAST IMPLANTS

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MENTOR BREAST IMPLANT SILICONE GEL, SMOOTH RND MODERATE PLUS PROFILE BREAST IMPLANTS Back to Search Results
Catalog Number 350-2501BC
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Raynauds Phenomenon (2034); Swelling (2091); Ulcer (2274); Urticaria (2278); Impaired Healing (2378)
Event Date 12/04/2013
Event Type  Injury  
Event Description
After getting breast implant in (b)(6) 2013, i had hives that lasted a year. In 2014 i started to get swelling in my fingers and toes. The swelling comes and goes. I developed raynaud's syndrome, and symptoms that look like rheumatoid arthritis, but a rheumatologist tested my blood and it was negative for this condition. I have ulcers on my fingers that will not heal.
 
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Brand NameBREAST IMPLANT SILICONE GEL, SMOOTH RND MODERATE PLUS PROFILE
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6237669
MDR Text Key64505589
Report NumberMW5067145
Device Sequence Number1
Product Code FTR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/09/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number350-2501BC
Device Lot Number6766471
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? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/09/2017 Patient Sequence Number: 1
Treatment
CYMBALTA 30MG DAILY; FISH OIL; MULTI VITAMIN ; ORTHO MICRONOR DAILY
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