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

Model Number	SCM-375
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported left side hematoma, infection, and capsular contracture baker grade iii.Device remains implanted.
Additional Manufacturer Narrative
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 and infection are physiological complications 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.Reason for reoperation: capsular contracture baker grade iii, infection (late onset).
Event or Problem Description
Patient reported left side hematoma, infection, and capsular contracture baker grade iii.Device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Fi summary: with the information collected during the investigation, there is enough evidence to support that device serial number (b)(6) was manufactured under controlled conditions in accordance with abbvie¿s procedures and were no defects/problems/issues found in the documents related to the reported event.Seal strength results were acceptable.Environmental monitoring results were found to be acceptable, and they confirmed that there was not an adverse impact on environmental conditions, device quality or performance.The sterilization run 30032369 is not related to any additional complaint infection record reported as of today.During the trend review of all gel infection complaints for the period of apr 2021 through mar 2023, no adverse trend was noted.Given the fact that the cause of the infection cannot be specifically associated to the manufacturing process, and there is not an adverse trend for this type of event, and no er/ ncr(s) or temporary changes were identified during the investigation associated to this lot and the complaint, no corrective action is deemed necessary at this time.
Event or Problem Description
Healthcare professional later reported and confirmed capsular contracture, baker grade iv.
Event or Problem Description
Patient reported left side hematoma, infection, and capsular contracture baker grade iii.Healthcare professional later reported and confirmed capsular contracture, baker grade iv.The device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.5., d.6b., g.2., h.6.
Additional Manufacturer Narrative
Visual analysis: visual analysis of the photographs identified: hematoma: unable to observe since it is not related to the device.Capsular contracture: unable to observe since it is not related to the device.Infection (late onset): unable to observe since it is not related to the device.No additional observations are performed.No further actions are required as no manufacturing issues are observed.
Event or Problem Description
Patient reported left side hematoma, infection, and capsular contracture baker grade iii.Healthcare professional later reported and confirmed capsular contracture, baker grade iv.The device has been explanted.

• Brand Name: INSPIRA SMOOTH COHESIVE SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• 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 ; 2525 dupont drive; building 3; irvine, CA 92612 ; 8479366324
• MDR Report Key: 16763772
• Report Number: 9617229-2023-06383
• Device Sequence Number: 6046992
• Product Code: FTR
• UDI-Device Identifier: 10888628029910
• UDI-Public: 10888628029910
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/03/2024

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: 09/24/2023
• Device Model Number: SCM-375
• Device Catalogue Number: SCM-375
• Device Lot Number: 3267173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 04/25/2023; 03/26/2024; 04/10/2024; 05/22/2024
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/11/2023; 03/29/2024; 04/23/2024; 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2018
• 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 Sex: Female
• Patient Weight: 87 KG