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

Model Number	TRF-450
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Date of Event	08/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient representative reported left side "fear of alcl", "mental anguish", ¿suffered aggravation of underlying conditions including emotional distress", "anxiety¿, "ptsd", "capsular contracture" baker grade unspecified, "seromas", ¿loss of quality of life¿ and ¿depression¿.Non-device related events of "chronic headache¿ and "chronic insomnia¿ were also reported.Unknown treatment and therapies were noted.The device has been explanted and replaced.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The reported events of capsular contracture and seroma are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Due to ongoing legal proceedings, follow-up is not possible at this time.Therefore additional event, product, and/or patient details are not attainable.The reason for reoperation is: "seromas", "capsular contracture" baker grade unspecified, and "fear of alcl".

• 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: 16681740
• Report Number: 9617229-2023-05963
• Device Sequence Number: 20630778
• Product Code: FTR
• UDI-Device Identifier: 10888628008342
• UDI-Public: 10888628008342
• 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
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2023

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 Expiration Date: 04/25/2021
• Device Model Number: TRF-450
• Device Catalogue Number: TRF-450
• Device Lot Number: 2914973
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2016
• 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: 49 YR
• Patient Sex: Female