MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA FULLPROF 385CC SIZER US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number	MSZ-F385
Medical Device Problem Codes	Difficult to Open or Remove Packaging Material (2922); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.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: difficult to open or remove packaging material.
Event or Problem Description
Sales representative reported ¿issues with the paper peeling off, causing sterility issues with the implant¿ and could not be opened.Later healthcare professional reported "the outer shrink wrap plastic and box were undamaged.The nurse peeled the paper (thermoform seal) from the clam shell, and it only partially separated from the plastic shell, leaving behind paper still fused to the outer clam shell.The outer thermoform seal did not appear damaged before opening on either shell.I personally tried to extract the inner clamp shell from the construct; however, the paper did separate, and i was unable to extract the sizer without contamination.".Device was not implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a3a, e1, e2, e3, g2, h6.
Event or Problem Description
Sales representative reported ¿issues with the paper peeling off, causing sterility issues with the implant¿ and could not be opened.Later healthcare professional reported "the outer shrink wrap plastic and box were undamaged.The nurse peeled the paper (thermoform seal) from the clam shell, and it only partially separated from the plastic shell, leaving behind paper still fused to the outer clam shell.The outer thermoform seal did not appear damaged before opening on either shell.I personally tried to extract the inner clamp shell from the construct; however, the paper did separate, and i was unable to extract the sizer without contamination.".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 inner and outer lid through visual inspection.None of the other observations performed during the device analysis (deformation, wear abrasion and creases) is found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.
Event or Problem Description
Sales representative reported ¿issues with the paper peeling off, causing sterility issues with the implant¿ and could not be opened.Later healthcare professional reported "the outer shrink wrap plastic and box were undamaged.The nurse peeled the paper (thermoform seal) from the clam shell, and it only partially separated from the plastic shell, leaving behind paper still fused to the outer clam shell.The outer thermoform seal did not appear damaged before opening on either shell.I personally tried to extract the inner clamp shell from the construct; however, the paper did separate, and i was unable to extract the sizer without contamination.".Device was not implanted it was returned.

• Brand Name: NATRELLE INSPIRA FULLPROF 385CC SIZER US
• Common Device Name: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• 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: 23053711
• Report Number: 9617229-2025-15619
• Device Sequence Number: 9321023
• Product Code: MRD
• UDI-Device Identifier: 10888628009325
• UDI-Public: (01)10888628009325(10)1271102(11)241102(17)291002
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K831566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2026

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: MSZ-F385
• Device Lot Number: 1271102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 09/16/2025; 12/22/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/02/2025; 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2024
• 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
• Patient Sex: Unknown