MAUDE Adverse Event Report: MENTOR SX RND MPP GEL-FILLED MAMMORY PROSTH; GEL-FILLED BREAST IMPLANT: DEVICE 1 -2"

Lot Number 265879

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Anaplastic Large Cell Lymphoma (3264)

Event Date 03/15/2016

Event Type  Injury  

Event Description

I have breast implants since 1993.In 2016 i had a breast reduction with old implants removed and new implants to put in.I was diagnosed with alcl in 2016.Went through chemo then had a stem cell transplant in (b)(6) 2016.

• Brand Name: SX RND MPP GEL-FILLED MAMMORY PROSTH
• Type of Device: GEL-FILLED BREAST IMPLANT: DEVICE 1 -2"
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6436022
• MDR Text Key: 70908687
• Report Number: MW5068673
• Device Sequence Number: 1
• Product Code: FTR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/24/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 265879
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: NONE; RX MEDS: SYNTHROID 88 MCG
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 76