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-410775
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Unspecified Infection (1930); Swollen Lymph Nodes/Glands (4432)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance's noted.The events of infection (unknown onset), seroma - late, and capsular contracture 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.Reason for reoperation: "infection, heat sensation;" "swelling, seroma;" "capsular contracture baker grade unknown, chronic pain, pain prior to explant procedure.".
Event or Problem Description
Patient representative reported left side ¿disfigurement,¿ ¿infection,¿ ¿chronic pain,¿ ¿pain prior to explant procedure,¿ ¿swelling,¿ ¿heat sensation,¿ ¿itching," "seroma,¿ ¿rashes,¿ ¿capsular contracture¿ baker grade unknown, ¿increased risk of alcl, mental pain, anguish and fear due to risk of alcl, mental pain and suffering," and "anxiety." patient representative additionally reported "depression," ¿disability,¿ ¿other past and future economic and non-economic damages such as medical care costs, lost wages, lost wage-earning capacity¿; these events are not device related.Device has been explanted and replaced.

• 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: 14621326
• Report Number: 9617229-2021-58254
• Device Sequence Number: 4456208
• Product Code: FTR
• UDI-Device Identifier: 10888628003040
• UDI-Public: 10888628003040
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/07/2022

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: 11/20/2021
• Device Model Number: FX-410775
• Device Catalogue Number: FX-410775
• Device Lot Number: 3003322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2016
• 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