MAUDE Adverse Event Report: MENTOR CONTOUR PROFILE SILTEX SALINE FILLED; BREAST IMPLANTS

Catalog Number	354-2711
Medical Device Problem Code	Appropriate Term/Code Not Available (3191)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
I have had mentor textured implants for 19 years.From the moment they were inserted under the muscle i had allergic type reaction.Subsided after 7 months of treatment.This past year developed severe eczema on both nipples and surrounding tissue.Eczema on about 50 percent of my body as well.Explanted (b)(6).By (b)(6).

• Brand Name: CONTOUR PROFILE SILTEX SALINE FILLED
• Common Device Name: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 7027561
• Report Number: MW5073307
• Device Sequence Number: 17310570
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2017
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 11/11/2017
• 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: 354-2711
• Device Lot Number: 154574
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OTC MEDS: NA. ; RX MEDS: ZRYTEC 10MG DAILY.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Weight: 57