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

Model Number	SRL-200
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	09/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Sales representative reported, on behalf of physician, a "right side capsular contracture, baker grade iii." device remains implanted.
Additional Manufacturer Narrative
Email: (b)(6).A review of the device history record has been completed.No deviations or non-conformances noted.The event of capsular contracture is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The reason for reoperation is: "capsular contracture, baker grade iii.".
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: weight to the spec, crease flat.Cloudy was observed after autoclave disinfection process.Based on the device analysis the final assessment is: no issues found related with the manufacturing process.
Event or Problem Description
Device has been explanted.
Event or Problem Description
Sales representative reported, on behalf of physician, a "right side capsular contracture, baker grade iii." device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.3., g.1.

• Brand Name: INSPIRA SMOOTH 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: 13803615
• Report Number: 9617229-2022-03406
• Device Sequence Number: 4006065
• Product Code: FTR
• UDI-Device Identifier: 10888628006683
• UDI-Public: 10888628006683
• Combination Product (Y/N): N
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2022

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: 09/29/2024
• Device Model Number: SRL-200
• Device Catalogue Number: SRL-200
• Device Lot Number: 3383653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 04/06/2022; 06/17/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 05/04/2022; 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2019
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 60 KG