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

Model Number	LX-410255
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient representative reported swelling to left breast, left breast pain, hardening, cold sensation, capsular contracture baker grade unknown and "seromas".Additional report of "symptoms consistent with alcl,¿ ¿mental anguish,¿ ¿disfigurement,¿ ¿interference with daily functions such as working/sleeping/exercising/other activities involving the left arm,¿ ¿negative effect on intimacy and self-image,¿ ¿other physical and emotional manifestations that are severe and ongoing¿ and painful removal procedures¿ which were all deemed not device related.The device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance's noted.The event of capsular contracture and seroma are physiological complications 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 and seroma.

• 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: 14339509
• Report Number: 9617229-2020-15054
• Device Sequence Number: 6256203
• Product Code: FTR
• UDI-Device Identifier: 10888628003316
• UDI-Public: 10888628003316
• 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: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2022

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: 12/22/2019
• Device Model Number: LX-410255
• Device Catalogue Number: LX-410255
• Device Lot Number: 2697181
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2015
• 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 Sex: Female