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

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.

• Brand Name: BREAST IMPLANT SILICONE GEL, SMOOTH RND MODERATE PLUS PROFILE
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6237669
• MDR Text Key: 64505589
• Report Number: MW5067145
• Device Sequence Number: 1
• Product Code: FTR
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 01/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 350-2501BC
• Device Lot Number: 6766471
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CYMBALTA 30MG DAILY; FISH OIL; MULTI VITAMIN ; ORTHO MICRONOR DAILY
• Patient Outcome(s): Disability
• Patient Age: 40 YR
• Patient Weight: 52