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

Model Number	TRX-400
Medical Device Problem Codes	Material Rupture (1546); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	07/28/2020
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, rupture.
Event or Problem Description
Patient reported unknown side " has textured implants" and "capsular contracture, or a rupture." device remains implanted.
Event or Problem Description
Additionally, patient reported right side rupture, "swelling", "inflammation", "pain", and "fever.".
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.

• 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; CS
• MDR Report Key: 10456754
• Report Number: 9617229-2020-13507
• Device Sequence Number: 14333700
• Product Code: FTR
• UDI-Device Identifier: 10888628008502
• UDI-Public: 10888628008502
• Combination Product (Y/N): N
• Initial Reporter State: NY
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2021

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: 01/25/2021
• Device Model Number: TRX-400
• Device Catalogue Number: TRX-400
• Device Lot Number: 2875253
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 02/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR