• 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 UNKNOWN GEL IMPLANT
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/14/2013
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. Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer. (b)(4). The device was not returned to mentor.

 
Event Description

This event was reported via # medwatch (mw5032276). It was reported that one female was implanted with mentor silicone breast implants in 2006. She was diagnosed with rheumatoid arthritis one year later. She had hashimoto¿s disease, chronic fatigue, brain fog, possible alcl according to the physician. She was scheduled to remove implants the following month. No contact information was provided in mw report, therefore no further information has been made available.

 
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
joaquin kurz
north irving , TX 75038-3540
9497893837
MDR Report Key6823172
Report Number1645337-2017-00074
Device Sequence Number1
Product CodeFTR
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 03/31/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN GEL IMPLANT
OTHER Device ID NumberUNKNOWN GEL IMPLANT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2017
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 Initial

Patient TREATMENT DATA
Date Received: 08/27/2017 Patient Sequence Number: 1
-
-