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

Catalog Number	SCM-375
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	08/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Photo analysis results: visual analysis of the photographs identified: capsular contracture: unable to observe.As it is a medical event, that is not related to the device.No additional observations.No further actions are required, since no issue in the manufacturing of the device is observed.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: capsular contracture, baker grade iii.
Event or Problem Description
Healthcare professional reported, left side capsular contracture, baker grade iii.Device has been explanted.
Event or Problem Description
Healthcare professional reported left side capsular contracture baker grade iii.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the photographs identified: capsular contracture : unable to observe as it is a medical event that is not related to the device.No additional observations.No further actions are required since no issue in the manufacturing of the device is observed.

• Brand Name: INSPIRA SMOOTH COHESIVE 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: 17841415
• Report Number: 9617229-2023-15718
• Device Sequence Number: 7173290
• Product Code: FTR
• UDI-Device Identifier: 10888628029910
• UDI-Public: 10888628029910
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2023

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 Catalogue Number: SCM-375
• Device Lot Number: 3662879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2022
• 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: 27 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White