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

Model Number	TCX-800
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Inflammation (1932)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information contained in this report was previously submitted through psr on 22/apr/2019.A review of the device history record has been completed.No deviations or non-conformances noted.The events of "capsular contracture and inflammation" 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: capsular contracture, baker grade unknown; "inflammation and stuff", and "pain/discomfort".
Event or Problem Description
Healthcare professional reported capsular contracture baker grade unknown.Additionally, patient reported "inflammation and stuff".Healthcare professional additionally reported "pain/discomfort"; these issues are not device related.The device was explanted.This record is for the left side.

• 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
• MDR Report Key: 9928575
• Report Number: 9617229-2019-05457
• Device Sequence Number: 14156762
• Product Code: FTR
• UDI-Device Identifier: 10888628031425
• UDI-Public: 10888628031425
• Combination Product (Y/N): N
• Initial Reporter State: IL
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2020

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: TCX-800
• Device Catalogue Number: TCX-800
• Device Lot Number: 3047139
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 04/06/2020
• 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