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

Model Number	TRF-345
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Unspecified Infection (1930); Seroma (2069)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.The events of capsular contracture baker grade unknown, seroma, infection are lymphadenopathy are a physiological complication 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, seroma, infection, lymphadenopathy.
Event or Problem Description
Healthcare professional reported left side implant exchange with no complaint against the device.Device has been explanted.Patient representative reported left side "breast pain", "painful removal procedures with the removal of the biocell textured breast implants due to fear of alcl, to reduce risk of alcl, and due to symptoms consistent with alcl and fear of alcl including mental anguish, increased risk of alcl, evaluation for alcl, explant, reconstruction, seromas, physical pain, scarring and disfigurement.", "double encapsulations," "asymmetry, indentations to chest", "severe pain from right shoulder/neck to right hand, excruciating pain in joints", "depression", "chronic and debilitating headaches,", "thick scarring near right under armpit and bilateral breasts, muscular twitching in right breast and shoulder, ringing in ears, chronic bloating and stomach discomfort, cognitive dysfunction and memory loss, stuttering, limited physical mobility, difficulty in daily activities such as showering, sitting, ambulating, working, and exercising, aggravation of underlying conditions including emotional distress and anxiety, other physical and emotional manifestations that are severe and ongoing.", ¿rashes on breasts, skin irritation, skin irritations and redness on shoulders and chest¿.Device has been explanted.

• 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 14880913
• Report Number: 9617229-2022-11290
• Device Sequence Number: 17415548
• Product Code: FTR
• UDI-Device Identifier: 10888628008304
• UDI-Public: 10888628008304
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2022

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: 02/16/2021
• Device Model Number: TRF-345
• Device Catalogue Number: TRF-345
• Device Lot Number: 2884970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2016
• 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: 29 YR
• Patient Sex: Female