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

Catalog Number	SRF-335
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event of "wound dehiscence and infection (late-onset)" 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.Reason for reoperation: wound dehiscence and infection (late-onset).
Event or Problem Description
Healthcare professional reported "infection".Later, healthcare professional reported capsular contracture, baker grade ii, hematoma, and "incision opened".Device has been explanted.This relates to the right side.
Event or Problem Description
Healthcare professional reported "infection".Later, healthcare professional reported capsular contracture, baker grade ii, hematoma, and "incision opened".Device has been explanted.This relates to the right side.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ capsular contracture: unable to observe as it is not related to the manufacturing process.¿ hematoma: unable to observe as it is not related to the manufacturing process.¿ infection (late onset): unable to observe as it is not related to the manufacturing process.¿ wound dehiscence: unable to observe as it is not related to the manufacturing process.As per the investigation procedure, creases, wear abrasion and deformation were completed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.
Event or Problem Description
Healthcare professional reported "infection".Later, healthcare professional reported capsular contracture, baker grade ii, hematoma, and "incision opened".Device has been explanted.This relates to the right side.

• 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; 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 ; 8479366324
• MDR Report Key: 21619338
• Report Number: 9617229-2025-04398
• Device Sequence Number: 6837762
• Product Code: FTR
• UDI-Device Identifier: 10888628007291
• UDI-Public: (01)10888628007291(10)1215369(11)231116(17)281016
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2025

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: SRF-335
• Device Lot Number: 1215369
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 04/03/2025; 04/24/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/22/2025; 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• 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: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White