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

Model Number	FX-410615
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Date of Event	08/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information contained in this report was previously submitted through 410psr on 01/22/2019 and 04/22/2019.A review of the device history record has been completed.No deviations or non-conformances noted.The events of capsular contracture and seroma-late are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The reason for reoperation: capsular contracture baker grade iii, seroma-late.
Event or Problem Description
Healthcare professional reported a right-side capsular contracture, baker grade iii.Healthcare professional additionally reported right side "late seroma".Device has been explanted.
Event or Problem Description
Healthcare professional reported a right-side capsular contracture, baker grade iii.Healthcare professional additionally reported right side "late seroma".Device has been explanted.
Additional Manufacturer Narrative
"device evaluation: analysis of the returned device identified: weight to spec, opening curved on anterior, crease fold and black particles in the shell.A visual and microscopic analysis was performed which identified: striated opening on anterior.Based on the device analysis the final assessment is: a striated opening on anterior assessed as surgical damage.Additional, changed, and/or corrected data: d9, h3, h6.

• 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 13636876
• Report Number: 9617229-2022-00460
• Device Sequence Number: 16675329
• Product Code: FTR
• UDI-Device Identifier: 10888628003026
• UDI-Public: 10888628003026
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2022

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: 12/31/2021
• Device Model Number: FX-410615
• Device Catalogue Number: FX-410615
• Device Lot Number: 3014584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2017
• 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: 37 YR
• Patient Sex: Female
• Patient Weight: 78 KG