MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA MODPROF 405CC SSZ US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number	SSZ-M405
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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: tyvek or thermoform sticking.
Event or Problem Description
Healthcare professional reported "when opening a sizer the paper was sticking to the sides of the plastic container.The remaining paper causes a sterility issue".This record is for an unknown side.Device was not implanted and there was no patient contact.

• Brand Name: NATRELLE INSPIRA MODPROF 405CC SSZ 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: 24313335
• Report Number: 9617229-2026-02581
• Device Sequence Number: 17538740
• Product Code: MRD
• UDI-Device Identifier: 10888628045682
• UDI-Public: (01)10888628045682(10)1284403(11)250127(17)291227
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203229
• 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
• Report Date (Section B): 02/11/2026

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: SSZ-M405
• Device Lot Number: 1284403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/11/2026
• Date Device Manufactured: 01/27/2025
• 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: Female