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

Catalog Number	115-435
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2024
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, anxiety-product/procedure.
Event or Problem Description
Healthcare professional reported \"exchange from textured to smooth\".Healthcare professional later reported \"ruptured\".Healthcare professional later reported \"hole, non-specific\".This record is for the left side.Device was explanted.

• 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: 50766106
• Report Number: 9617229-2026-17555
• Device Sequence Number: 15759258
• Product Code: FTR
• UDI-Device Identifier: 10888628002425
• UDI-Public: (01)10888628002425(17)191224
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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: 12/24/2019
• Device Catalogue Number: 115-435
• Device Lot Number: 2697694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/02/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/15/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 01/24/2015
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 155 LB