MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) Inspira Smooth Silicone Gel Filled Breast Implant; prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	SRX-615
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Malposition of Device (2616); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported "sitting a little higher".This record is for the left side.Device remains implanted.
Additional Manufacturer Narrative
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: malposition of device.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Reason for reoperation: capsular contracture baker grade unknown.
Event or Problem Description
Patient reported "sitting a little higher".Patient later reported "capsular contracture baker grade unknown".This record is for the left side.Device remains implanted.
Event or Problem Description
Healthcare professional originally reported "sitting a little higher" and "capsular contracture baker grade unknown" and later confirmed that these events did not occur.The device has been explanted.This record is no longer reportable to fda and will be un-reported.
Additional Manufacturer Narrative
Additional, changed, and/or corrected date: b2, b5, d3, d6b and h6.

• 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; la aurora de heredia ; CS
• Manufacturer (Section G): Allergan (Costa Rica); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; +1(847)936-6324
• MDR Report Key: 24280330
• Report Number: 9617229-2026-02491
• Device Sequence Number: 8318483
• Product Code: FTR
• UDI-Device Identifier: 10888628007598
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SRX-615
• Device Lot Number: 1233721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 02/20/2026; 09/08/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/16/2026; 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2024
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 150 LB
• Patient Race: Native Hawaiian Or Other Pacific Islander