MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 15 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	15-659
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Device was explanted.
Event or Problem Description
Healthcare professional reported "rupture" diagnosed by ultrasound.This record is for the right side.Device remains implanted.
Additional Manufacturer Narrative
Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.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.Reason for reoperation: rupture.
Event or Problem Description
Healthcare professional reported "rupture" diagnosed by ultrasound.This record is for the right side.Device was explanted.
Additional Manufacturer Narrative
Device evaluation: based on the product analysis performed, the assessments of the complaints are: ¿ rupture: observed broken on radius side assessed as fold flaw opening.As per the investigation procedure, creases, wear abrasion and non-penetrating nicks were completed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.
Additional Manufacturer Narrative
Correction to g.3.Aware date of supplemental medwatch #1.Aware date should have been listed as 19jun2024.
Event or Problem Description
Healthcare professional reported right side rupture.Device has been explanted.

• Brand Name: STYLE 15 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: 19575942
• Report Number: 9617229-2024-15466
• Device Sequence Number: 3943803
• Product Code: FTR
• UDI-Device Identifier: 10888628001558
• UDI-Public: 10888628001558
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/02/2025

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: 08/07/2015
• Device Catalogue Number: 15-659
• Device Lot Number: 2011082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 06/03/2024; 08/10/2024; 09/09/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 07/11/2024; 08/27/2024; 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2010
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White