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-345
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
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.Trend summary confirmed: the review of historical complaints on the complaint management handling indicates that there were no other records related to this event for units manufactured on lot number 1284276.The search criteria of these queries are mentioned on qpp07-01-004-her1-g02 rev: 7.0 the review of all potential trend evaluations for breast implants closed during the past 12 months indicates that no confirmed complaint trends have been observed for (b)(6) unsealed device packaging and (b)(6) difficult to open or remove packaging material.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: tyvek or thermoform sticking.
Event or Problem Description
Healthcare professional reported "tyvek paper didn¿t come off" and "ended up breaking sterile field".The device was not implanted.
Additional Manufacturer Narrative
Device evaluation: per the analysis performed, the assessments of the complaints and any potential manufacturing issue are displayed along with any further actions required: ¿ tyvek or thermoform sticking: observed delamination of outer lid through visual inspection.None of the other observations performed during the device analysis (intact and functional) is found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.
Event or Problem Description
Healthcare professional reported "tyvek paper didn¿t come off" and "ended up breaking sterile field".The device was not 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: 23069556
• Report Number: 9617229-2025-15725
• Device Sequence Number: 21250572
• Product Code: FTR
• UDI-Device Identifier: 10888628029897
• UDI-Public: (01)10888628029897(10)1284276(11)250131(17)291231
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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-345
• Device Lot Number: 1284276
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2025
• 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
• Patient Sex: Unknown