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

Model Number	TRF-770
Medical Device Problem Codes	Material Rupture (1546); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Cellulitis (1768); Unspecified Infection (1930)
Date of Event	08/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: (b)(6) 2018: oxygen therapy.(b)(6) 2018: oxygen therapy.(b)(6) 2018: oxygen therapy.(b)(6) 2018: nebulizer treatment (respiratory).(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 infection (early onset), cellulitis, capsular contracture, and wound dehiscence 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: infection (early onset), cellulitis, capsular contracture, baker grade ii/iii; wound dehiscence.
Event or Problem Description
Documentation received from patient representative notes that the patient contacted the primary care physician approximately two months post implant concerned about indications of an infection.The primary care physician suggested that the patient go to the er where they were admitted.The patient was hospitalized for approximately five days.The events reported to occur are as follows: presented with fever, chills -- sepsis was suspected, chest pain, infected wound, pain, aching, discomfort, pressure, burning sensation, right breast with mild erythema, cellulitis and skin infection, pain and redness, fever, chills, cellulitis of breast, left breast edema/cellulitis with a small wound positive for (b)(6), and right breast exploration with small wound.The following events have been deemed not related to the device: ecchymosis, bruising, breast rash from tegaderm, shortness of breath, and nausea.After patient was released from the hospital further events were reported as follows: grade ii/iii capsule on the right, anxiety, and soreness.The following events have been deemed not related to the device: fatigue, insomnia, decreased exercise tolerance, asthma, wheezing, weight gain, acute bronchitis/wheezing (cough, fever, chest congestion, fatigue), and central breast on both sides reveal a dermatitis with fewer vesicles, less weeping, and a drying rash; dermatitis; complains of eczema (itchy rash on fingers and toes).Affected side is right.The device remains implanted.
Additional Manufacturer Narrative
Reason for reoperation: rupture.
Event or Problem Description
Patient later reported right side rupture and autoimmune type symptoms (not device related) due to the 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; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 9949995
• Report Number: 9617229-2020-07235
• Device Sequence Number: 11546228
• Product Code: FTR
• UDI-Device Identifier: 10888628008427
• UDI-Public: 10888628008427
• Combination Product (Y/N): N
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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: 01/04/2021
• Device Model Number: TRF-770
• Device Catalogue Number: TRF-770
• Device Lot Number: 2864904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H.10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 95 KG