MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	FX-410690
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/20/2023
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 infection (late onset) is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for the event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time fi summary: with the information collected during the investigation, there is enough evidence to support that device serial number (b)(6) was manufactured under controlled conditions in accordance with abbvie¿s procedures and were no defects/problems/issues found in the documents related to the reported event.Seal strength was successfully completed and results were acceptable.Environmental monitoring results were found to be acceptable, and they confirmed that there was not an adverse impact on environmental conditions, device quality or performance.The sterilization run (b)(6) is not related to any additional complaint infection record reported as of today.Considering that there is no adverse trend for this type of event, no additional actions are deemed required at this time.The issue with infection will continue to be monitored and corrective actions will be taken in the future if deemed appropriate.Given the fact that the cause of the infection cannot be specifically associated to the manufacturing process, and there is not an adverse trend for this type of event, and no er/ ncr(s) or temporary changes were identified during the investigation associated to this lot and the complaint, no corrective action is deemed necessary at this time.Reason for reoperation: infection (late onset).
Event or Problem Description
Healthcare professional reported left side "infection, redness, wound, and exchange from textured to smooth implants due to the patients concern with the product".Device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, h6.
Event or Problem Description
Device has been explanted and replaced.
Event or Problem Description
Healthcare professional reported, left side "infection, redness wound.And exchange from textured to smooth implants, due to the patients concern with the product".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 confirm, as it is a medical event.Not related to the device.Infection late onset: not observed.No further actions are required, as no manufacturing issues are observed.

• Brand Name: STYLE 410 COHESIVE 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 ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 18133925
• Report Number: 9617229-2023-18716
• Device Sequence Number: 17752225
• Product Code: FTR
• UDI-Device Identifier: 10888628003033
• UDI-Public: 10888628003033
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 01/12/2024

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: 08/21/2020
• Device Catalogue Number: FX-410690
• Device Lot Number: 2804975
• 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: 10/24/2023
• Supplement Date Received by Manufacturer: 11/17/2023; 01/10/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 12/14/2023; 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2015
• 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: 57 YR
• Patient Sex: Female