MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA FULLPROF 450CC SIZER US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number	MSZ-F450
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.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
Company representative reported the box of the sizer was malfunctioning and really hard to open.Later, healthcare professional reported "device packaging difficult to remove, compromising sterility of implant".Device was not implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d1, d3, d4, d9, g1, h3, h4, h6.Device evaluation: per the investigation procedure, the device is analyzed through visual inspection microscopic inspection if openings are observed and a weight verification.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: not observed through visual inspection.No additional observations performed on the device.No further actions are required.
Event or Problem Description
Company representative reported the box of the sizer was malfunctioning and really hard to open.Later, healthcare professional reported "device packaging difficult to remove, compromising sterility of implant".Device was not implanted.

• Brand Name: NATRELLE INSPIRA FULLPROF 450CC 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: 22309309
• Report Number: 9617229-2025-10331
• Device Sequence Number: 8081833
• Product Code: MRD
• UDI-Device Identifier: 10888628009349
• UDI-Public: (01)10888628009349(10)1244499(11)240516(17)290416
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MSZ-F450
• Device Lot Number: 1244499
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown