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 Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not implanted or used once packaging was opened.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.The reason complaint: ¿issues with the paper peeling off, causing sterility issues with the implant¿ and could not be opened.Later healthcare professional reported "the box and the shrink wrap plastic around the box were undamaged.Then the nurse attempted to open the inner clamshell by peeling off the paper (thermoform).The paper split in two and did not separate from the plastic shell.It did not appear damaged.I can not comment on the inner seal because we never go to see that one because the outer seal never separated correctly.".
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 box and the shrink wrap plastic around the box were undamaged.Then the nurse attempted to open the inner clamshell by peeling off the paper (thermoform).The paper split in two and did not separate from the plastic shell.It did not appear damaged.I can not comment on the inner seal because we never go to see that one because the outer seal never separated correctly.".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
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 box and the shrink wrap plastic around the box were undamaged.Then the nurse attempted to open the inner clamshell by peeling off the paper (thermoform).The paper split in two and did not separate from the plastic shell.It did not appear damaged.I can not comment on the inner seal because we never go to see that one because the outer seal never separated correctly.".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: 23034100
• Report Number: 9617229-2025-15487
• Device Sequence Number: 9682452
• Product Code: MRD
• UDI-Device Identifier: 10888628009325
• UDI-Public: (01)10888628009325(10)1259058(11)240821(17)290721
• 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: Health Professional,Company Representative
• 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: MSZ-F385
• Device Lot Number: 1259058
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• 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: Female