MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA FULLPROF 560CC SSZ US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number	SSZ-F560
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a follow-up report to a medwatch submitted under manufacture report number 9617229-2023-17229.A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation: based on the device analysis grid, the assessments of the complaint are: breach of sterile barrier seal: unable to observer since the thermoform is open.No additional observations are performed.No further actions are required as no manufacturing issues are observed.Further investigation summary: the review of the documentation associated to the manufacturing process indicates that all devices with the same lot number were released in accordance with abbvie¿s procedures and were no defects/problems/issues found in the documents or in the personnel training related to the reported event.Additionally, no er/ ncr(s) were identified during the investigation associated with this lot and the complaint.According to the complaint review the packages has not been received for analysis in the device analysis laboratory yet.A review of the current risk documents was performed and the event of compromised sterility is a known event, for which manufacturing process controls and inspections are stablished to reduce the incidence of this defect.Per evaluation performed in this investigation this case is not confirmed as high impact complaint, and no further actions are required at this time.During the trend review of all breach of sterile barrier seal complaints for gel breast implant for the period indicated, was noted one outlier.The additional analysis performed shows all that results met the acceptance criteria and no issues, deviations or non-conformances were found which could be associated to the breach of sterile barrier seal event, so, no additional actions are deemed required at this time.The issue with breach of sterile barrier seal will continue to be monitored and corrective action taken in the future if deemed appropriate.Additional, changed, and/or corrected data: g4, h6 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: device was not implanted.
Event or Problem Description
Healthcare professional reported "breast sizer was opened and st noticed that the package was not completely sealed and therefore not sterile".The device was not implanted.

• Brand Name: NATRELLE INSPIRA FULLPROF 560CC 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: 23279884
• Report Number: 9617229-2025-17421
• Device Sequence Number: 8956116
• Product Code: MRD
• UDI-Device Identifier: 10888628045132
• UDI-Public: (01)10888628045132(10)3573213(11)211130(17)261030
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/13/2025

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-F560
• Device Lot Number: 3573213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• 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