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

Catalog Number	MX-410620
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
Continued: h.6.F2201.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 unknown.
Event or Problem Description
Patient reported right side "breast pain." device was explanted.Healthcare professional later reported pain, "appears bigger" and "current implants have been recalled".Healthcare professional later reported capsular contracture baker grade unknown.The device has been explanted.
Event or Problem Description
Patient reported, right side "breast pain".Device was explanted.Healthcare professional, later reported, pain, "appears bigger" and "current implants have been recalled".Healthcare professional, later reported, capsular contracture, baker grade unknown.The device has been explanted.
Event or Problem Description
Patient reported, right side "breast pain".Healthcare professional, later reported, pain, "appears bigger".And "current implants have been recalled".Healthcare professional, additionally reported, capsular contracture, baker grade unknown.The device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the product analysis performed, the assessments of the complaints are: anxiety-product/procedure: unable to observe, as it is not related to the device.Pain: unable to observe, as it is not related to the device.Visibility/palpability: unable to observe, as it is not related to the device.Cancer-ndr: unable to observe, as it is not related to the device.Other-medical-ndr: unable to observe, as it is not related to the device.Capsular contracture: unable to observe, as it is not related to the device.As per the investigation procedure: deformation, particles, wear abrasion and creases were completed.And none of the observations are found to be potentially related to the manufacturing process, no further actions are required.

• 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 ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 19250411
• Report Number: 9617229-2024-0011303
• Device Sequence Number: 17751937
• Product Code: FTR
• UDI-Device Identifier: 10888628003781
• UDI-Public: 10888628003781
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2024

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: 12/23/2021
• Device Catalogue Number: MX-410620
• Device Lot Number: 3012386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 05/08/2024; 06/22/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 05/12/2024; 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2017
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 79 KG