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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 350-3250
Device Problems Material Rupture; Adverse Event Without Identified Device or Use Problem
Event Date 02/23/2015
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. (b)(4). The device was not returned to mentor.

 
Event Description

It was reported that a (b)(6) female patient underwent bilateral breast prostheses implantation with mentor saline implants on (b)(6) 2005. Patient presented with bilateral implant deflation with defective valves. She also reported mold, fungus and bio-toxins were leaking into her body. Patient had implants explanted on (b)(6) 2014. 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 Key6498500
Report Number1645337-2017-00033
Device Sequence Number1
Product CodeFWM
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 02/23/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/17/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number350-3250
Device LOT Number5610526-045
OTHER Device ID Number350-3250
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: 04/17/2017 Patient Sequence Number: 1
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