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

Model Number	TRM-375
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069); Lymphoma (3263)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance's noted.The reported events of "capsular contracture, baker grade iii" and "seroma-late" 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 iii and seroma-late.
Event or Problem Description
Healthcare reported bilateral exchange from textured to smooth implants due to the patients concerns with the product.Healthcare professional additionally reported capsular contracture , baker grade ii/iii and seroma.This is for the left side.Device has been explanted.
Event or Problem Description
Healthcare professional reported "positive for anaplastic large cell lymphoma".Cd30+ biomarker was received.Alk- biomarker has not been received.
Additional Manufacturer Narrative
Device evaluation:analysis of the returned device identified: weight to spec, deformation device and yellow particles in the shell.Air voids and cloudy in the gel observed after autoclave cycle.Base on the device analysis the final assessment is: no issues found related with the manufacturing process.Oncology contact information: (b)(6).

• 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: 14962549
• Report Number: 9617229-2022-11701
• Device Sequence Number: 14795572
• Product Code: FTR
• UDI-Device Identifier: 10888628008120
• UDI-Public: 10888628008120
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2022

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: 02/03/2021
• Device Model Number: TRM-375
• Device Catalogue Number: TRM-375
• Device Lot Number: 2878366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2016
• 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: CELEXA, SYNTHROID, HORMONE PELLETS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 53 KG