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

Catalog Number	MX-410445
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Unspecified Infection (1930); Breast Discomfort/Pain (4504); Swelling/ Edema (4577)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported right side swelling, pain, "hot to the touch", redness and implant exchange from textured to smooth due to the patients concerns with the product.Device remains implanted.Patient was treated with antibiotic medication (cephalexin).
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 reported events are physiological complications and analysis of the device generally does not assist abbvie in determining a probable cause for these events.Reason for reoperation: pain, edema, and erythema.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, h6 the event of infection is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Reason for reoperation: infection.
Event or Problem Description
Patient reported infection and "shooting and burning pain.".

• 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 ; 8479366324
• MDR Report Key: 22631238
• Report Number: 9617229-2025-12617
• Device Sequence Number: 13012396
• Product Code: FTR
• UDI-Device Identifier: 10888628003750
• UDI-Public: (01)10888628003750(10)2697184(11)150127(17)191227
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: 12/27/2019
• Device Catalogue Number: MX-410445
• Device Lot Number: 2697184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/21/2025
• Date Device Manufactured: 01/27/2015
• 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: 37 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White