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

MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

  • 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 TEXAS MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE Back to Search Results
Catalog Number 3503420
Device Problem Device Contamination with Chemical or Other Material
Event Date 08/01/2017
Event Type  Injury  
Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed. The device history record (dhr) review is in progress. A supplemental report will be submitted upon its completion. Manufacturer's ref. No:(b)(4).

 
Event Description

It was reported that a female patient underwent bilateral explantation of mentor smooth round high profile saline breast implants. The patient underwent implantation on (b)(6) 2007. Approximately two weeks after the procedure, the patient began to experience a number of symptoms, including extreme anxiety, numbness, tingling, joint pain, brain fog, memory loss, confusion, vision problems, food allergies, difficulty walking, breathing issues, muscle atrophy and hormonal issues. Redness was noted on the left breast, and bilateral pain/burning was experienced approximately 5 years post-procedure. There was no previous history of autoimmune disease. Six months after receiving the implants, the patient underwent a full hysterectomy, as the physicians thought that perhaps her issues were hormonal in nature. Visual contrast sensitivity and human beta growth factor tests were administered. Mold toxicity was suspected, so the patient underwent bilateral explantation on (b)(6) 2015. Capsular contracture and fungal growth were diagnosed in both breasts/implants upon explantation. No extended hospitalization was required. Patient outcome has since improved, with lingering food allergies, gut issues and mold/chemical sensitivity.

 
Manufacturer Narrative

On 11/6/2017, a device history record (dhr) review was performed for this device. As a result, the manufacturing date, expiration date and udi fields have been updated. The device history record (dhr) of lot number 5748581 was reviewed and no anomalies were found related to this complaint. In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures. (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMENTOR SMOOTH ROUND HIGH PROFILE
Type of DevicePROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
Manufacturer (Section D)
MENTOR TEXAS
3041 skyway circle north
irving TX 75038
Manufacturer (Section G)
MENTOR TEXAS
3041 skyway circle north
irving TX 75038
Manufacturer Contact
joaquin kurz
3041 skyway circle north
irving , TX 75038
949789-383
MDR Report Key7001971
Report Number1645337-2017-00134
Device Sequence Number1
Product CodeFWM
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/03/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2011
Device Catalogue Number3503420
Device LOT Number5748581
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/01/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/03/2017 Patient Sequence Number: 1
-
-