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

Model Number	TRX-650
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924); Seroma (2069)
Date of Event	12/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The events of "seroma 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: seroma and capsular contracture.
Event or Problem Description
Patient reported right side exchange from textured to smooth breast implants due to the patient¿s concern with the product and reported "right side is inflamed, painful, and fluid build up and capsular contracture all on one side,¿ the baker grade is unknown.Device remains implanted.
Event or Problem Description
Healthcare professional reported right side rupture per ct scan.
Additional Manufacturer Narrative
Reason for reoperation: "rupture".

• 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
• MDR Report Key: 11178631
• Report Number: 9617229-2020-22751
• Device Sequence Number: 14049659
• Product Code: FTR
• UDI-Device Identifier: 10888628008601
• UDI-Public: 10888628008601
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2021

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: 06/04/2020
• Device Model Number: TRX-650
• Device Catalogue Number: TRX-650
• Device Lot Number: 2766734
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 02/18/2021
• 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: 30 YR
• Patient Weight: 75