MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 120 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	120-340
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	03/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.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
Healthcare professional reported right side "swelling with small seroma pocket" and "biocell device." device has been explanted.
Event or Problem Description
Healthcare professional reported right side "swelling with small seroma pocket" and "biocell device." device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ anxiety - product/procedure: unable to observe as it is not related to the device.¿ seroma: unable to observe as it is not related to the device.¿ edema: unable to observe as it is not related to the device.Additional observations: ¿ deformation observed.No further actions are required as no manufacturing issues are observed.
Event or Problem Description
Healthcare professional reported right side "swelling with small seroma pocket" and "biocell device." device has been explanted.
Additional Manufacturer Narrative
Correction to g.3.Aware date of supplemental medwatch #1.Aware date should have been listed as 05/dec/2023.

• Brand Name: STYLE 120 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 ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 18015825
• Report Number: 9617229-2023-31216
• Device Sequence Number: 15348875
• Product Code: FTR
• UDI-Device Identifier: 10888628002548
• UDI-Public: 10888628002548
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2025

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: 12/27/2013
• Device Catalogue Number: 120-340
• Device Lot Number: 1699954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 10/23/2023; 09/09/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 12/27/2023; 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2009
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White