MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT

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.

• Type of Device: BREAST 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 Key: 6765990
• MDR Text Key: 81785259
• Report Number: 1645337-2017-00049
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN GEL IMPLANT
• Other Device ID Number: UNKNOWN GEL IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2017
• Initial Date FDA Received: 08/03/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 55 YR