MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT

Catalog Number	UNKNOWN GEL IMPLANT
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Impaired Healing (2378); No Code Available (3191); Anaplastic Large Cell Lymphoma (3264)
Date of Event	05/01/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• MDR Report Key: 6765990
• Report Number: 1645337-2017-00049
• Device Sequence Number: 9873621
• Product Code: FTR
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: UNKNOWN GEL IMPLANT
• Other Device ID Number: UNKNOWN GEL IMPLANT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 08/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 55 YR