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

Catalog Number	468-450
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported "no complaint against the device".Later healthcare professional reported "biocell recall case is coming up.Patient will have to remove textured saline implants to replace smooth silicone implants".Later healthcare professional reported "deflation".This is for the right side.Device was explanted and replaced and will return.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: 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: ¿ deflation: observed multiple openings through microscopic inspection 1 opening assessed as unidentified (tear) opening and 1 opening assessed as surgical damage.No further actions are required as it is not related to the manufacturing process.¿ anxiety-product/procedure: unable to observe through visual inspection as it is a physiological phenomenon.None of the other observations performed during the device analysis (creases and broken of plug strap) are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.
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 "no complaint against the device".Later healthcare professional reported "biocell recall case is coming up.Patient will have to remove textured saline implants to replace smooth silicone implants".Later healthcare professional reported "deflation".This is for the right side.Device was explanted and replaced and will return.

• 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): 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: 23464887
• Report Number: 9617229-2025-18838
• Device Sequence Number: 9950006
• Product Code: FWM
• UDI-Device Identifier: 10888628001145
• UDI-Public: 10888628001145
• 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: 2014
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/07/2017
• Device Catalogue Number: 468-450
• Device Lot Number: 2458280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 11/29/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: Asian