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

Catalog Number	350-2501BC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Raynauds Phenomenon (2034); Swelling (2091); Ulcer (2274); Urticaria (2278); Impaired Healing (2378)
Date of Event	12/04/2013
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6237669
• Report Number: MW5067145
• Device Sequence Number: 16582197
• Product Code: FTR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 01/09/2017
• 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?: No
• Operator of Device: No Information
• Device Catalogue Number: 350-2501BC
• Device Lot Number: 6766471
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CYMBALTA 30MG DAILY; FISH OIL; MULTI VITAMIN ; ORTHO MICRONOR DAILY
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 40 YR
• Patient Weight: 52