MAUDE Adverse Event Report: Allergan (Costa Rica) Style 410 Cohesive Silicone Gel Filled Breast Implant; prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	MF-410195
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient´s spouse reported "infections and swelling in their breasts".This record is for the right side.The device remains implanted.
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 event of infection (unknown onset) is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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: infection (unknown onset).

• 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; la aurora de heredia ; CS
• Manufacturer (Section G): Allergan (Costa Rica); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; +1(847)936-6324
• MDR Report Key: 50441809
• Report Number: 9617229-2026-16146
• Device Sequence Number: 13055518
• Product Code: FTR
• UDI-Device Identifier: 10888628003422
• UDI-Public: (01)10888628003422(17)180403
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: 04/03/2018
• Device Catalogue Number: MF-410195
• Device Lot Number: 2455932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/11/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 08/25/2026
• Supplement Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 05/03/2013
• 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: Other
• Patient Sex: Female