MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 115 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	115-253
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported via customer portal left side rupture, double capsule, seroma, "scattered papillary growth", "breast enlargement / pain", and "textured".Device has been explanted.
Additional Manufacturer Narrative
Visual analysis of the photographs identified: ¿ rupture: observed but cannot perform an assessment of the opening as no microscopic analysis can be performed.¿ pain: unable to observe since it is not related to the device.¿ seroma: unable to observe since it is not related to the device.¿ double capsule: unable to observe since it is not related to the device.¿ visibility/palpability: unable to observe since it is not related to the device.¿ anxiety-product/ procedure: unable to observe since it is not related to the device.No additional observations are performed.No further actions are required as no manufacturing issues are observed.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The event of "seroma-late" 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: device rupture and seroma-late.
Event or Problem Description
Healthcare professional reported, via customer portal left side rupture.Double capsule, seroma, "scattered papillary growth", "breast enlargement/pain" and "textured".Device has been explanted.
Event or Problem Description
Healthcare professional reported via customer portal left side rupture, double capsule, seroma, "scattered papillary growth", "breast enlargement / pain", and "textured".Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the product analysis performed, the assessments of the complaint codes are: ¿ visibility/palpability: unable to observe as it is not related to the manufacturing process.¿seroma: unable to observe as it is not related to the manufacturing process.¿rupture: observed an opening assessed as fold flaw opening ¿pain: unable to observe as it is not related to the manufacturing process.¿double capsule: unable to observe as it is not related to the manufacturing process.¿anxiety - product/ procedure: unable to observe as it is not related to the manufacturing process.As per the investigation procedure, crease/wear abrasion were observed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.

• Brand Name: STYLE 115 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: 20678819
• Report Number: 9617229-2024-24261
• Device Sequence Number: 8556809
• Product Code: FTR
• UDI-Device Identifier: 10888628002357
• UDI-Public: 10888628002357
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2025

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: 12/06/2014
• Device Catalogue Number: 115-253
• Device Lot Number: 1796352
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 11/19/2024; 12/11/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 12/03/2024; 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2010
• 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: 49 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian