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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 3504004BC
Device Problems Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Autoimmune Disorder (1732); Pain (1994); No Code Available (3191)
Event Date 10/03/2016
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. (b)(4). This device was not returned to mentor.
 
Event Description
It was reported that a (b)(6) female patient underwent bilateral breast prostheses implantation with mentor gel implants on (b)(6) 2013. Patient presented with bilateral implant rupture. She also suffered persistent mild hardening, fatigue, weakness, high homocysteine, moderate c-reactive protein, photosensitivity, hives, itching after sun exposure, brittleness and cracking of nails, easy bruising, shortness of breath, cognitive difficulties, metallic taste in mouth, night sweats, headaches, foul body odor, cognitive dysfunction, nausea, dizziness, hashimoto¿s disease, skin rashes, digestive and gastrointestinal issues, low white blood cells, elevated thyroid and autoimmune antibodies, epstein-barr virus, cytomegalovirus, varicella zoster, and pain (generalized). Patient was bedridden. She had breast asymmetry on the right side. Patient also had delayed wound healing, infection, lymphadenopathy on the left side. Dense breast tissue was confirmed by ultrasound. Patient had implants explanted on (b)(6) 2016. No further information was obtained.
 
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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
joaquin kurz
north irving, TX 75038-3540
9497893837
MDR Report Key6495684
MDR Text Key72876649
Report Number1645337-2017-00030
Device Sequence Number1
Product Code FTR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number3504004BC
Device Lot Number6694760-060
Other Device ID Number3504004BC
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
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: 04/14/2017 Patient Sequence Number: 1
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