• 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 MODERATE 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 MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE Back to Search Results
Model Number 3501655
Device Problem Device Contamination with Chemical or Other Material
Event Date 11/01/2016
Event Type  Injury  
Manufacturer Narrative

The mentor failure analysis lab received the device for evaluation. The analysis has begun but is not completed at this time. When the investigational analysis has been completed, a supplemental 3500a report will be submitted. The device history record (dhr) 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. Manufacturer's ref. No: (b)(4).

 
Event Description

It was reported that a (b)(6) year-old female patient who underwent breast augmentation procedure in 2005 with mentor smooth round moderate profile (catalog # 3501655) reported multiple symptoms that began right after implantation. The patient reported severe nipple pain, fatigue, joint pain, hair loss, and overall sickness. The patient underwent explantation procedure on (b)(6) 2016. It was reported that the inside of the valve and the outside of the implant had mold. The implants were intact upon explantation. The patient reports that her health is slowly improving but the nipple pain resolved immediately after explantation.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMENTOR SMOOTH ROUND MODERATE 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 Key6983886
Report Number1645337-2017-00125
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 Received10/27/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/13/2008
Device MODEL Number3501655
Device Catalogue Number3501655
Device LOT Number5548928
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/09/2017
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 Manufactured08/16/2004
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: 10/27/2017 Patient Sequence Number: 1
-
-