MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 468 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	468-270
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	08/01/2025
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: deflation.
Event or Problem Description
Patient reported deflation and exchange from textured to smooth due to the patient¿s concern of the product.This record is for the right side.Device remains implanted.
Additional Manufacturer Narrative
Clarification d.6a: partial date of implant (b)(6) 1995 reported in initial emdr is incorrect since this is before the manufacturing date of the device (21/may/1996) which is not possible.Hence partial date of implant is being unreported.
Event or Problem Description
Patient reported deflation and exchange from textured to smooth due to the patient¿s concern of the product.This record is for the right side.Device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d6a.
Event or Problem Description
Patient reported deflation and exchange from textured to smooth due to the patient¿s concern of the product.This record is for the right side.Device remains implanted.

• Brand Name: STYLE 468 SALINE FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer (Section G): SANTA BARBARA; 900 parkway global park zona f; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 23671333
• Report Number: 9617229-2025-20602
• Device Sequence Number: 13201876
• Product Code: FWM
• UDI-Device Identifier: 10888628001107
• UDI-Public: 10888628001107
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1995
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2026

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: 04/01/2000
• Device Catalogue Number: 468-270
• Device Lot Number: 2-522536
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 01/02/2026; 01/15/2026
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 01/14/2026; 01/15/2026
• Date Device Manufactured: 05/21/1996
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Hispanic
• Patient Race: White