• 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 SALINE IMPLANT
Device Problem Device Contamination with Chemical or Other Material
Event Date 09/30/2013
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 is event was reported via # mw5034717. It was reported that a female patient received bilateral augmentation mammoplasty in 1998. The patient reported that in mid 2013 she experienced breast pain in the right breast and skin rash and swelling in her right side. These symptoms have been lasting for 4-5 years. The patient reported easy bruising and body swelling. She was diagnosed as biotoxin illness, silicone sensitivity from the silicon shell of the saline implant, mold coming from the implant. According to her physician fibromyalgia, mastodynia, hashimoto¿s thyroiditis and raynaud¿s disease were false positive and her illness was actually due to the biotoxin disease from the mold.

 
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 Key6734648
Report Number1645337-2017-00045
Device Sequence Number1
Product CodeFWM
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 07/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN SALINE IMPLANT
OTHER Device ID NumberUNKNOWN SALINE 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 Received06/23/2017
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

Patient TREATMENT DATA
Date Received: 07/21/2017 Patient Sequence Number: 1
-
-