MAUDE Adverse Event Report: Allergan (Costa Rica) Natrelle Inspira FullProf 485cc SSZ US; sizer, mammary, breast implant volume

Catalog Number	SSZ-F485
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Healthcare professional reported "opening a sizer in the operating room" and that the "inner packaging wasn't sealed all the way".There was no patient contact.This record is for the unimplanted device.Surgery was completed using a backup device.
Additional Manufacturer Narrative
Further information regarding event and product details has been requested.No additional information is available at this time.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.Reason for report: "opening a sizer in the operating room" and that the "inner packaging wasn't sealed all the way".

• Brand Name: Natrelle Inspira FullProf 485cc 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 ; +1(847)936-6324
• MDR Report Key: 50714069
• Report Number: 9617229-2026-17247
• Device Sequence Number: 10611578
• Product Code: MRD
• UDI-Device Identifier: 10888628045118
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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-F485
• Device Lot Number: 1365569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 02/10/2026
• 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