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-600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Unspecified Infection (1930)
Date of Event	08/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.A review of the device history record has been completed.No deviations or non-conformances noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.The reason for reoperation was/is infection.Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.
Event or Problem Description
Healthcare professional reported a left side "infection".Device has been explanted.
Additional Manufacturer Narrative
Further investigation results: with the information collected during the investigation, there is enough evidence to support that device serial number (b)(6) was manufactured under controlled conditions in accordance with allergan medical procedures.Environmental monitoring results were found to be acceptable and they confirmed that there was not an adverse impact on environmental conditions, device quality or performance.The sterilization run 30026576 is not related to any additional complaint infection record reported as of today.During the trend review of all infection complaints for gel breast implants for the period of sep 2017 through aug 2019, was noted an outlier in (b)(6) 2017.An additional analysis was performed to determine any pattern or any similarities relation between pr¿s involved.It was found that some primary packaging operators were involved in more than one occasion, however the people were trained in the corresponding procedure.Also, calibrations, maintenance and validations of the equipments involved in more than one occasion were reviewed and it was determined that they were performed on time and met specifications.In addition, all the records involved in this month was reviewed and no issues, deviations or ncs were found associated to either event.Given the fact that the cause of the infection cannot be specifically associated to costa rica manufacturing process, and there is not an adverse trend for this type of event no corrective action is deemed necessary at this time.
Event or Problem Description
Healthcare professional reported a left side "infection." device has been explanted.
Event or Problem Description
Healthcare professional added, "cellulitis of breast.".
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.5, g.1, h.6.

• 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; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 9503550
• Report Number: 9617229-2019-16130
• Device Sequence Number: 16644654
• Product Code: FTR
• UDI-Device Identifier: 10888628030978
• UDI-Public: 10888628030978
• Combination Product (Y/N): N
• Initial Reporter State: CO
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2022

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: 03/27/2022
• Device Model Number: TCM-600
• Device Catalogue Number: TCM-600
• Device Lot Number: 3047566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 02/10/2021; 03/25/2021
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 03/11/2021; 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2017
• 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: 58 YR
• Patient Sex: Female