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

MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC 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 WORLDWIDE LLC BREAST IMPLANT Back to Search Results
Catalog Number 350-1680
Device Problems Material Rupture; Defective Component; Device Contamination with Chemical or Other Material
Event Type  Injury  
Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a. Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made. Manufacturer's ref. No: (b)(4).

 
Event Description

It was reported that a female patient underwent a breast augmentation surgery using mentor saline smooth round moderate profile implants on (b)(6) 2003. The patient suffered sternal pain, mastodynia and mold infection manifested as enlarged lymph nodes, and was diagnosed bio-toxin disease in 2015. The implants were removed surgically on (b)(6) 2015 and found to have defective valves, internal debris and determined to have been leaking.  .

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
MENTOR WORLDWIDE LLC
3041 skyway circle
north irving TX 75038 3540
Manufacturer (Section G)
MENTOR WORLDWIDE LLC
3041 skyway circle
north irving TX 75038 3540
Manufacturer Contact
carl hansen
north irving , TX 75038-3540
9497893858
MDR Report Key6643555
Report Number1645337-2017-00038
Device Sequence Number1
Product CodeFWM
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 05/18/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/15/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number350-1680
Device LOT NumberUNKNOWN
OTHER Device ID Number350-1680
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-