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

Catalog Number 354-2711

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/05/2017

Event Type  Injury  

Event 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
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 7027561
• MDR Text Key: 91928115
• Report Number: MW5073307
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• 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: 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
• Device Operator: No Information
• Device Catalogue Number: 354-2711
• Device Lot Number: 154574
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: NA. ; RX MEDS: ZRYTEC 10MG DAILY.
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 57