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

Model Number	MF-410640
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Lymphoma (3263)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hcp who may have additional information: dr.(b)(6).A review of the device history record has been completed.No deviations or non-conformances noted.The events of lymphoma - alcl - suspected and seroma - late 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: seroma (300cc); cd30+ alcl.
Event or Problem Description
Healthcare professional reported a patient with left side seroma (300cc).Fluid was aspirated and cytology noted that the fluid was "consistent with breast implant-associated anaplastic large cell lymphoma." while the marker of cd30+ has been reported, the marker of alk- has not.The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified deformation, cloudy and yellow particles material was found on the shell.A weight test of the device was verified and the device was within specification.Based on the device analysis the final assessment is: no issues found related with the manufacturing.
Event or Problem Description
Healthcare professional reported a patient with left side seroma (300cc).Fluid was aspirated and cytology noted that the fluid was "consistent with breast implant-associated anaplastic large cell lymphoma." while the marker of cd30+ has been reported, the marker of alk- has not.The device has been explanted.
Event or Problem Description
Healthcare professional reported a patient with left side seroma (300cc).Fluid was aspirated and cytology noted that the fluid was "consistent with breast implant-associated anaplastic large cell lymphoma." while the marker of cd30+ has been reported, the marker of alk- has not.The device has been explanted.

• Brand Name: STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 11563578
• Report Number: 9617229-2021-04366
• Device Sequence Number: 4846168
• Product Code: FTR
• UDI-Device Identifier: 10888628003521
• UDI-Public: 10888628003521
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2022

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: 01/26/2020
• Device Model Number: MF-410640
• Device Catalogue Number: MF-410640
• Device Lot Number: 2710729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 04/28/2021; 05/19/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 05/17/2021; 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 81 KG