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

Catalog Number	68-510
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "pain" and "rupture" of a saline device.Patient was prescirbed with tylenol.This record is for the left side.Device remains implanted.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Continued e1: alternate phone number: (b)(6).Continued e1: alternate address: (b)(6).A review of the device history record has been completed.No deviations or non-conformances noted.Further information regarding event, product, or patient details has been requested/will be requested.No additional information is available at this time.Reason for reoperation: rupture of a saline device (deflation).
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, h6.

• 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): Santa Barbara; 900 parkway global park zona f; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; +1(847)936-6324
• MDR Report Key: 50721847
• Report Number: 9617229-2026-17304
• Device Sequence Number: 8861929
• Product Code: FWM
• UDI-Device Identifier: 10888628000285
• 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: 2003
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 01/28/2004
• Device Catalogue Number: 68-510
• Device Lot Number: 549804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/26/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/10/2026
• Supplement Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 03/07/2000
• 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
• Patient Age: 66 YR
• Patient Sex: Female