MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA FULLPROF 365CC SIZER US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number	MSZ-F365
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.A review of the device history record has been completed.No deviations or non-conformances noted.Reason for reoperation: tyvek/thermoform sticking.
Event or Problem Description
Company representative reported "breast sizer would not open sterilely.Unable to use product".Device was not implanted.
Event or Problem Description
Company representative reported "breast sizer would not open sterilely.Unable to use product".Device was not implanted.
Additional Manufacturer Narrative
Device evaluation based on the product analysis performed, the assessments of the complaint codes are: tyvek or thermoform sticking: unable to observe since no device package was received.As per the investigation procedure, creases and deformation were observed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.Additional, changed, and/or corrected data: b1, b2, d.9., h.3., h.6.

• Brand Name: NATRELLE INSPIRA FULLPROF 365CC 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: 21826301
• Report Number: 9617229-2025-06094
• Device Sequence Number: 9301412
• Product Code: MRD
• UDI-Device Identifier: 10888628009318
• UDI-Public: (01)10888628009318(10)1236839(11)240405(17)290305
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MSZ-F365
• Device Lot Number: 1236839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2024
• 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: Female