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

Model Number	FF-410740
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Lymphoma (3263); Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) (4549)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 "seroma-late and lymphoma-alcl" 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: lymphoma-alcl-suspected, seroma-late.Physician: (b)(6).
Event or Problem Description
Patient reported left side "alcl".Patient reported "breast cancer" which is not related to the device.Healthcare professional reported "bia-alcl" and "400 ml seroma." pathological marker cd30+ has been received.Pathological marker alk- has not been received.The device has been explanted.
Event or Problem Description
Additional events of calcification, pain, depression, lymphedema and lymphadenopathy, events deemed to be not device related.
Event or Problem Description
Healthcare professional confirmed alcl histopathological markers cd30 positive and alk negative.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.5, b.6, h.6, h7, h9.

• 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: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 15298459
• Report Number: 9617229-2022-14882
• Device Sequence Number: 17641655
• Product Code: FTR
• UDI-Device Identifier: 10888628002739
• UDI-Public: 10888628002739
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2022

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: 06/24/2020
• Device Model Number: FF-410740
• Device Catalogue Number: FF-410740
• Device Lot Number: 2781335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 08/25/2022; 09/15/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 09/22/2022; 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2011068-7/2/19-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 104 KG