MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA FULLPROF 485CC SIZER US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number	MSZ-F485
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
Event or Problem Description
Company representative on behalf of healthcare professional 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", no patient contact.Device was not implanted.
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.Reason for reoperation: tyvek or thermoform sticking.
Event or Problem Description
Company representative on behalf of healthcare professional 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", no patient contact.Device was not implanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Dhr trend summary: the review of historical complaints on the complaint management handling system identified that there was another record for units manufactured on lot number 1212420: - (b)(4): tyvek or thermoform sticking (a020501 difficult to open or remove packaging material), use error (a2301 device handling problem).Device not returned to device analysis.Even though there was one additional complaint of tyvek or thermoform sticking for this lot number, the devices has not been returned to confirm the event or to detect a potential workmanship.The search criteria of these queries are mentioned on qpp07-01-004-her1-g02 revision 6.0.The review of all potential trend evaluations for breast implants closed during the past 12 months indicates that no confirmed complaint trends have been observed for the events tyvek or thermoform sticking (a020501 difficult to open or remove packaging material), a1801 (contamination).
Additional Manufacturer Narrative
Device evaluation: the device related to the reported events tyvek or thermoform sticking was received on january 26, 2026 with lot number [only thermoform received, device not received].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 485CC 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: 22296100
• Report Number: 9617229-2025-10219
• Device Sequence Number: 8310430
• Product Code: MRD
• UDI-Device Identifier: 10888628009356
• UDI-Public: (01)10888628009356(10)1212420(11)231020(17)280920
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 03/02/2026

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: MSZ-F485
• Device Lot Number: 1212420
• 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: 07/03/2025; 02/16/2026
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/30/2025; 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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