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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC BREAST IMPLANT

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MENTOR WORLDWIDE LLC BREAST IMPLANT Back to Search Results
Catalog Number UNKNOWN GEL IMPLANT
Device Problem Material Rupture
Event Date 05/20/2015
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

It was reported that the patient replaced saline implants which was implanted on (b)(6) 2003 with mentor cohesive gel implants in (b)(6) 2011. The patient felt discomfort which she had not previously experienced. After approximately 1. 5 years, she began to suffer from serious health issues, including but not limited to, constant headaches, difficulty with concentration and focusing, constant pain and swelling in left breast, high anxiety, shoulder and neck pain, obsessive compulsive disorder, muscle weakness, symptoms that resembled fibromyalgia, insomnia, memory issues and other symptoms resembling chronic fatigue syndrome. She became very ill and had been sick during a business trip, with a fever, swollen left breast and lymph node infection. Patient took advil, various muscle relaxants, heat and other remedies. Patient was diagnosed with left implant rupture around (b)(6) 2015 and got implant removed on (b)(6) 2015. Patient felt symptom-free almost immediately after removing implants. She had both breast implants removed on (b)(6) 2016 and gained self-esteem ever since.

 
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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 Key6734607
Report Number1645337-2017-00042
Device Sequence Number1
Product CodeFTR
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? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN GEL IMPLANT
Device LOT NumberUNKNOWN
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 Received08/03/2016
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
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