MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 68 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	68-750
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported "infection, calcification and inflammation".This record is for the left side.Device was explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The event of "infection (unknown onset)" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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: infection.(unknown onset).
Event or Problem Description
Patient later reported left side red, and warm to the touch.Patient was treated with iv antibiotics.
Additional Manufacturer Narrative
In response to fda report number: mw5175083, mw517084, mw5175085 additional, changed, and/or corrected data: a4; b5; b7; g2.

• 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 ; 8479366324
• MDR Report Key: 22998154
• Report Number: 9617229-2025-15189
• Device Sequence Number: 13115147
• Product Code: FWM
• UDI-Device Identifier: 10888628000339
• UDI-Public: (01)10888628000339(10)3552916(11)210921(17)250821
• 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 Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2025
• Device Catalogue Number: 68-750
• Device Lot Number: 3552916
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/21/2025
• Date Device Manufactured: 09/21/2021
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Hispanic
• Patient Race: White