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

Catalog Number	20-350
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	01/01/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported capsular contracture, baker grade unknown, "shifting and feeling different lately", "size of a softball", "discomfort towards armpit" and "very hard".This record is for the left side.The device remains implanted.
Additional Manufacturer Narrative
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/will be requested.No additional information is available at this time.The reason(s) for reoperation is/are: capsular contracture, grade unknown.The reported event or events are physiological complications (capsular contracture, grade unknown), and device analysis typically does not help allergan determine the cause.Clarification to reported partial onset(b3) date: 2014.

• 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: 24945411
• Report Number: 9617229-2026-07283
• Device Sequence Number: 5241445
• Product Code: FTR
• UDI-Device Identifier: 10888628001688
• UDI-Public: 10888628001688
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2015
• Device Catalogue Number: 20-350
• Device Lot Number: 2034757
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/21/2026
• Date Device Manufactured: 10/26/2010
• 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: 40 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White