MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE INSPIRA LOWPROF 200CC SSZ US; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number	SSZ-L200
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.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: difficult to open or remove packaging material.
Event or Problem Description
Regulatory agency, on behalf of healthcare professional, reported an unknown side sizer device "top cover of the packing was not peeling cleanly and left some leftover paper attached to the plastic container" and "there was no serious harm reported".The device was not implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: e1, h1.
Event or Problem Description
Regulatory agency, on behalf of healthcare professional, reported an unknown side sizer device "top cover of the packing was not peeling cleanly and left some leftover paper attached to the plastic container" and "there was no serious harm reported".The device was not implanted.
Event or Problem Description
Regulatory agency, on behalf of healthcare professional, reported an unknown side sizer device "top cover of the packing was not peeling cleanly and left some leftover paper attached to the plastic container" and "there was no serious harm reported".The device was not implanted.
Additional Manufacturer Narrative
Clarification to h6 adverse event problem and h11 additional mfg narrative: healthcare professional returned only the packaging for analysis, captured by b19 incomplete device returned.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: observed delamination of outer lid through visual inspection.No additional observations performed on the device.No further actions are required.Additional, changed, and/or corrected data: d3, d9, g1, h3, h6, h11.

• Brand Name: NATRELLE INSPIRA LOWPROF 200CC 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: 24014895
• Report Number: 9617229-2026-00616
• Device Sequence Number: 15691585
• Product Code: MRD
• UDI-Device Identifier: 10888628045231
• UDI-Public: (01)10888628045231(10)1305550(11)250604(17)300504
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K203229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/26/2026

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-L200
• Device Lot Number: 1305550
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 02/11/2026; 04/30/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 03/02/2026; 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• 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