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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 01/31/2017
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 product is not returned.

 
Event Description

It was reported that the patient has suffered bodily injury and resulting pain and suffering, disability, mental anguish, loss of capacity for the enjoyment of life, hospitalization, medical and nursing care and treatment, loss of ability to earn money in the future. Patient also had developed rashes and pruritis. Dermatologist and allergist were seen without relief. The patient sought treatment from several physicians, who concluded that the implants were responsible for patient¿s condition. The patient had the implants surgically removed on (b)(6) 2017, at which time the surgeon noted that the implants were leaking. Pathological evaluation of the patient¿s lymph nodes, removed during the explantation surgery, revealed reactive histiocytosis which is associated with silicone leaking from the prostheses.

 
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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 Key6749011
Report Number1645337-2017-00046
Device Sequence Number1
Product CodeFTR
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 07/27/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/2017
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 Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2017
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: 07/27/2017 Patient Sequence Number: 1
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