MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	MF-410525
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Lymphoma (3263)
Date of Event	06/15/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.The events of lymphoma - alcl - suspected and death are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: diagnosis of lymphoma cd30 positive; passed away.
Event or Problem Description
Patient representative reported patient's discomfort.Patient developed a cough and saw pulmonologist and cardiologist with no diagnosis given.Symptoms grew to sores all over body and not sleeping as well as the persistent cough and was taken to the hospital in which patient stayed for 17 days and sent home with diagnosis of lymphoma cd30 positive.The patient has passed away.The marker of alk(-) has not been reported or confirmed.Affected side is left.The device remains implanted.
Additional Manufacturer Narrative
In response to fda report number: mw5098354.Patient representative reported via regulatory agency "hospitalization leading to death due to hodgkin's lymphoma." as alcl is a non-hodgkin lymphoma this event as well as the related death have been deemed not related to the device per allergan medical safety.
Event or Problem Description
Patient representative reported via regulatory agency "hospitalization leading to death due to hodgkin's lymphoma." as alcl is a non-hodgkin lymphoma this event as well as the related death have been deemed not related to the device per allergan medical safety.

• Brand Name: STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• MDR Report Key: 11135762
• Report Number: 9617229-2020-22532
• Device Sequence Number: 631005
• Product Code: FTR
• UDI-Device Identifier: 10888628003507
• UDI-Public: 10888628003507
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2021

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 Expiration Date: 10/25/2019
• Device Model Number: MF-410525
• Device Catalogue Number: MF-410525
• Device Lot Number: 2679214
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 02/18/2021
• 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: Death; Hospitalization
• Patient Age: 71 YR