MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 20 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	20-600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported "no complaint against the device".Later healthcare professional reported "fluid".This 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.The event of "seroma" 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: seroma.
Event or Problem Description
Patient reported left side "no complaint against the device".Healthcare professional later reported "fluid".Device has been explanted and replaced.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a5, a6, b5, b6.
Event or Problem Description
Patient reported "no complaint against the device".Later healthcare professional reported "fluid".This is for the left side.The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the product analysis performed, the assessments of the complaint codes are: ¿ seroma: unable to observed.A workmanship was observed not related to the complaint for a observed split (ss) in patch area event.A further investigation is requested.As per the investigation procedure, deformation and creases were observed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.Additional, changed, and/or corrected data: b.5., d.6b., d.9., h.2., h.3., h.6.

• Brand Name: STYLE 20 SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• 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: 22507658
• Report Number: 9617229-2025-11804
• Device Sequence Number: 9247076
• Product Code: FTR
• UDI-Device Identifier: 10888628001763
• UDI-Public: (01)10888628001763(10)2798821(11)150904(17)200804
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2025

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: 08/04/2020
• Device Catalogue Number: 20-600
• Device Lot Number: 2798821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 08/22/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/11/2025; 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2015
• 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: 38 YR
• Patient Sex: Female
• Patient Weight: 100 KG