MAUDE Adverse Event Report: Allergan (Costa Rica) Style 68 Saline Filled Breast Implant; prosthesis, breast, inflatable, internal, saline

Catalog Number	68-360
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported ¿deflation¿.This record is for the right side.Device remains implanted.
Additional Manufacturer Narrative
Clarification to d6a - partial implant date provided as 2009.Date in d6a was adjusted/removed as device was not manufactured until 09/jan/2009.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 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 ; +1(847)936-6324
• MDR Report Key: 50717479
• Report Number: 9617229-2026-17278
• Device Sequence Number: 13224742
• Product Code: FWM
• UDI-Device Identifier: 10888628000230
• UDI-Public: (01)10888628000230(17)121206
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: 12/06/2012
• Device Catalogue Number: 68-360
• Device Lot Number: 1693959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/24/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/10/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 01/09/2009
• 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: Other; Required Intervention
• Patient Sex: Female
• Patient Weight: 125 LB
• Patient Race: White