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

Model Number	TCM-405
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported left side "bacterial infection".Healthcare professional reported left side removal/replacement of textured for smooth implants.Patient representative additionally reported significantly increased risk of developing cancer, emotional distress including fear and anxiety of developing cancer, accumulation of foreign and adulterated silicone particles in their bodies, including the resulting inflammation, cellular damage, and subcellular damage, physical pain and suffering.The events of "adulterated silicone particles in their bodies, cellular damage, and subcellular damage" have been 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-conformances noted.The event of "infection (early onset)" 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: infection (early onset).

• Brand Name: INSPIRA TEXTURE 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: 14918987
• Report Number: 9617229-2022-11526
• Device Sequence Number: 6204544
• Product Code: FTR
• UDI-Device Identifier: 10888628030923
• UDI-Public: 10888628030923
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/05/2022

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: 07/19/2021
• Device Model Number: TCM-405
• Device Catalogue Number: TCM-405
• Device Lot Number: 2950859
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2016
• 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 Age: 55 YR
• Patient Sex: Female