• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MENTOR CONTOUR PROFILE SILTEX SALINE FILLED; BREAST IMPLANTS Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONTOUR PROFILE SILTEX SALINE FILLED
Type of Device
BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key7027561
MDR Text Key91928115
Report NumberMW5073307
Device Sequence Number1
Product Code FWM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received11/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number354-2711
Device Lot Number154574
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
OTC MEDS: NA. ; RX MEDS: ZRYTEC 10MG DAILY.
Patient Outcome(s) Other;
Patient Age48 YR
Patient Weight57
-
-