MAUDE Adverse Event Report: MENTOR MENTOR MEMORY SHAPE BREAST IMPLANT; SILICONE GEL IMPLANTS

Model Number	REF 354-1708
Health Effect - Clinical Code	Anaplastic Large Cell Lymphoma (3264)
Date of Event	06/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Pt with breast implants s/p reconstruction for cancer.Pt was three years out from exchange of implants.Pt developed fluid around right breast implant.Fluid eval done, pt found to have breast implant associated anaplastic large cell lymphoma.(bia-alcl).Implant and capsule removed.Pt found to have smooth gel implants- mentor memory shape breast implant.

• Brand Name: MENTOR MEMORY SHAPE BREAST IMPLANT
• Common Device Name: SILICONE GEL IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6849535
• Report Number: MW5072020
• Device Sequence Number: 15518781
• Product Code: FTR
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/06/2017
• 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
• Operator of Device: No Information
• Device Model Number: REF 354-1708
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2017
• 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: Other
• Patient Age: 56 YR