MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 15 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	15-213
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The event of capsular contracture 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: capsular contracture, baker grade iv.
Event or Problem Description
Patient reported, left side "rippling, folds, discomfort, pain lumps.And when i press, the implant moves".Healthcare professional, later reported, a left side capsular contracture, baker grade iv.Device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, h6.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: the device related to the reported event of lump/nodule, pain, wrinkling, crease/folding of implant, capsular contracture and device migration was received on january 22, 2025 with lot number 2724526.Based on the device analysis grid, the assessments of the complaint are: lump/nodule: unable to observe as it is not related to the manufacturing process.Pain: unable to observe as it is not related to the manufacturing process.Crease/folding of implant and wrinkling: observed creases on device.Capsular contracture: unable to observe as it is not related to the manufacturing process.Device migration: unable to observe as it is not related to the manufacturing process.As per the investigation procedure deformation and wear abrasion were completed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.
Event or Problem Description
Patient reported left side "rippling, folds, discomfort, pain lumps and when i press the implant moves".Healthcare professional later reported a left side capsular contracture baker grade iv.Device has been explanted.

• Brand Name: STYLE 15 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 19131380
• Report Number: 9617229-2024-0011230
• Device Sequence Number: 4658580
• Product Code: FTR
• UDI-Device Identifier: 10888628001411
• UDI-Public: 10888628001411
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2025

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: 03/16/2020
• Device Catalogue Number: 15-213
• Device Lot Number: 2724526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 12/04/2024; 02/14/2025
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 12/06/2024; 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2015
• 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 Sex: Female
• Patient Weight: 49 KG