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

MAUDE Adverse Event Report: MENTOR MENTOR SMOOTH GEL BREAST IMPLANT

  • 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 MENTOR SMOOTH GEL BREAST IMPLANT Back to Search Results
Model Number 350-3501BC
Event Date 11/30/2016
Event Type  Injury  
Event Description

Two weeks after getting great implants, lymph nodes began to swell and are still swollen. Right implant capsulated and became painful. C reactive protein is measuring 48 or higher. Six months after implants got (b)(6), along with unexplained weight loss, reoccurring shingles, and fatigue. The list goes on.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMENTOR SMOOTH GEL BREAST IMPLANT
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key7027562
Report NumberMW5073308
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 11/12/2017
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
Device Operator NO INFORMATION
Device MODEL Number350-3501BC
Device Catalogue Number350-3501BC
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/13/2017 Patient Sequence Number: 1
-
-