MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) Style 115 Silicone Gel Filled Breast Implant; prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	115-354
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.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: rupture, pain, visibility/palpability.
Event or Problem Description
Healthcare professional reported "rupture", "pain" and "distortion of breasts".This record is for the right side.The device remains implanted.
Event or Problem Description
Healthcare professional reported "rupture", "pain" and "distortion of breasts".This record is for the right side.Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, d9, h3, h6.Device evaluation: per the analysis performed, the assessments of the complaints and any potential manufacturing issue are displayed along with any further actions required: - rupture: observed broken device through microscopic inspection assessed as fold flaw opening.No further actions are required as it is not related to the manufacturing process.- pain: unable to observe through visual inspection as it is a physiological phenomenon.- visibility/palpability: unable to observe through visual inspection as it is a physiological phenomenon.None of the other observations performed during the device analysis creases are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.¿this report was impacted by emdr scheduled maintenance occurring july 22-27, 2026.¿.

• Brand Name: Style 115 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: 24458717
• Report Number: 9617229-2026-03668
• Device Sequence Number: 10052404
• Product Code: FTR
• UDI-Device Identifier: 10888628002395
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2015
• Device Catalogue Number: 115-354
• Device Lot Number: 1811963
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/29/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2010
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 135 LB