MAUDE Adverse Event Report: SANTA BARBARA STYLE 468 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	468-300
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "deflation".This record is for the left side.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 requested.No additional information is available at this time.Reason for reoperation: deflation.

• Brand Name: STYLE 468 SALINE FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): SANTA BARBARA; 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer (Section G): SANTA BARBARA; 900 parkway global park zona f; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 25376785
• Report Number: 9617229-2026-10339
• Device Sequence Number: 21485207
• Product Code: FWM
• UDI-Device Identifier: 10888628001114
• UDI-Public: (01)10888628001114(17)990501
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

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: 05/01/1999
• Device Catalogue Number: 468-300
• Device Lot Number: 2-518870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 06/03/2026
• Date Device Manufactured: 07/08/1995
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 59 KG