MAUDE Adverse Event Report: Allergan (Costa Rica) Style 468 Saline Filled Breast Implant; prosthesis, breast, inflatable, internal, saline

Catalog Number	468-380
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury

• 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 ; +1(847)936-6324
• MDR Report Key: 50747520
• Report Number: 9617229-2026-17451
• Device Sequence Number: 18358348
• Product Code: FWM
• UDI-Device Identifier: 10888628001138
• UDI-Public: (01)10888628001138(17)110105
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2026

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: 01/05/2011
• Device Catalogue Number: 468-380
• Device Lot Number: 1388582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/13/2026
• Date Device Manufactured: 02/08/2007
• 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: 44 YR
• Patient Sex: Female