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-195
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "the paper was shredding on both the inner and outer packaging upon opening.The paper lid did not come off in one solid piece as the other implants do when opening, leaving fibers that end up in the sterile area where the implant is".The device was implanted, side unspecified.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d9, h3, h6.Device evaluation: based on the product analysis performed, the assessments of the complaint codes are: tyvek or thermoform sticking: observed delamination in the lid.No additional observations performed on the device.No further actions are required.
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.A review of the device history record has been completed.No deviations or non-conformance's noted.Reason for reoperation: tyvek or thermoform sticking.
Event or Problem Description
Healthcare professional reported "the paper was shredding on both the inner and outer packaging upon opening.The paper lid did not come off in one solid piece as the other implants do when opening, leaving fibers that end up in the sterile area where the implant is.¿.This record is for an unknown side.Device remains implanted.

• 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; 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: 22851364
• Report Number: 9617229-2025-14192
• Device Sequence Number: 4362125
• Product Code: FTR
• UDI-Device Identifier: 10888628029811
• UDI-Public: (01)10888628029811(10)1280625(11)250114(17)291214
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SCM-195
• Device Lot Number: 1280625
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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: Unknown