MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 68 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	68-750
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported saline rupture (deflation) and indicated the device will be available for return.This record is for the left side.The device remains implanted.
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/will be requested.No additional information is available at this time.The reason(s) for reoperation is/are: deflation.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, h6.
Event or Problem Description
The device has been explanted and replaced.

• Brand Name: STYLE 68 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): 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: 23076798
• Report Number: 9617229-2025-15775
• Device Sequence Number: 4966028
• Product Code: FWM
• UDI-Device Identifier: 10888628000339
• UDI-Public: (01)10888628000339(10)1192735(11)230619(17)270519
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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 Catalogue Number: 68-750
• Device Lot Number: 1192735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 02/18/2026
• Date Device Manufactured: 06/19/2023
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 57 KG