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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 (1546)
Patient Problems Impaired Healing (2378); No Code Available (3191); Anaplastic Large Cell Lymphoma (3264)
Event Date 05/01/2017
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 device was not returned to mentor.

 
Event Description

It was reported that a (b)(6) year-old female underwent primary augmentation surgery using mentor silicone implants. On (b)(6) 2016 she underwent revision operation due to breast implant leak. Right implant was found with thick fibrous capsule as well as intracapsular leak upon removal. Breast tissue was not sent for histology at that time. After revision surgery, the patient experienced delay of wound healing and had two scar revision operations. After 2nd scar revision surgery, breast tissue was sent for pathology and she was diagnosed with implant-related anaplastic large cell lymphoma on (b)(6) 2017. Site of lymphoma: right side. It was unknown whether cd30 positive or alk negative. Alcl stage and alcl treatment are unknown. Multiple attempts have been made to obtain clarification on catalog, lot number and manufacture site of the devices that were used during this procedure. However, no further information has been made available.

 
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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 Key6765990
MDR Text Key81785259
Report Number1645337-2017-00049
Device Sequence Number1
Product Code FTR
Combination Product (Y/N)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 08/03/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN GEL IMPLANT
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 Received07/06/2017
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: 08/03/2017 Patient Sequence Number: 1
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