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

Model Number	TRM-255
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event of capsular contracture 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: capsular contracture, baker grade unknown.
Event or Problem Description
Patient reported capsular contracture, baker grade unknown.The device has been explanted.This relates to the right side.
Additional Manufacturer Narrative
Photo analysis visual analysis of the photographs identified: capsular contracture : unable to confirm as it is a medical event not related to the device.Observed an opening the device but cannot perform an assessment of the opening as no microscopic analysis can be performed.It is not possible to determine the lot number or catalog through the photos provided.
Event or Problem Description
Patient reported capsular contracture, baker grade unknown.The device has been explanted.This relates to the right side.
Event or Problem Description
Patient reported right side capsular contracture, baker grade unknown.Device has been explanted and replaced with a non-allergan device.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data.

• Brand Name: INSPIRA TEXTURED 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: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 16591729
• Report Number: 9617229-2023-04912
• Device Sequence Number: 20070467
• Product Code: FTR
• UDI-Device Identifier: 10888628008052
• UDI-Public: 10888628008052
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2023

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 Model Number: TRM-255
• Device Catalogue Number: TRM-255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 05/25/2023; 07/05/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 06/14/2023; 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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